LiposarcomaProstate healthCancerMen's healthWomen's healthDrugCombination productPhase 1, Phase 2
What this study is
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.
Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort.
Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.
The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant.
In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion.
In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).
In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted.
In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI).
In Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide.
In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE.
Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060.
Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively.
Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy.
Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen.
The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK.
The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.
What's being tested
- PF-07220060
Intervention · DRUG
CDK4 inhibitor
- Letrozole
Intervention · COMBINATION PRODUCT
- Fulvestrant
Intervention · COMBINATION PRODUCT
- Midazolam
Intervention · OTHER
Benzodiazepine
- Enzalutamide
Intervention · COMBINATION PRODUCT
Androgen Receptor inhibitor
- Giredestrant
Intervention · COMBINATION PRODUCT
- Tamoxifen
Intervention · COMBINATION PRODUCT
All of Letrozole, Fulvestrant, Giredestrant, Tamoxifen
Endocrine Therapy
Study details
- Official title
- A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
- Sponsor
- Pfizer
- Conditions
- Liposarcoma · Prostate Cancer · Advanced Breast Cancer · NSCLC (Non-small Cell Lung Cancer) · Colorectal Cancer
- Enrolling
- 430 people
- Starts
- 2020-09-23
- Est. completion
- 2029-10-07
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedPart 1
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 1: Breast Cancer (BC); Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC; Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC
- Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 1F
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 1F: prostate cancer
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 1G
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 1G: HR-positive/HER2-negative BC
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 2A
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 2B
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 2C
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 2E
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 2F
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Part 1D
You may qualify if
- All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Adequate renal, liver, and bone marrow function
- Part 1D: metastatic castration resistant prostate cancer
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- Prior systemic Treatment; Part 1: HR-positive/HER2-negative BC; At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator; HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy; Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available; Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed; Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC; Part 2C:; Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or; Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal; One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy; Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
You can't join if
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 4 weeks prior to study intervention
- Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- Pregnant or breastfeeding female participant
- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (39)
10 openSmilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States
RecruitingYale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States
RecruitingSmilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
RecruitingYale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, United States
RecruitingSmilow Cancer Hospital - Trumbull
Trumbull, Connecticut, United States
RecruitingSTART Midwest
Grand Rapids, Michigan, United States
RecruitingSarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
RecruitingSCRI Oncology Partners
Nashville, Tennessee, United States
RecruitingThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RecruitingThe University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, United States
RecruitingEllison Institute
Los Angeles, California, United States
Active, not recruitingBrigham & Women's Hospital
Boston, Massachusetts, United States
Active, not recruitingDana-Farber Cancer Institute
Boston, Massachusetts, United States
Active, not recruitingDana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, United States
Active, not recruiting
25 sites outside the US
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Active, not recruitingFundación Cenit Para La Investigación En Neurociencias
CABA, Ciudad Autã³noma de Buenos Aires, Argentina
Active, not recruitingFundación Respirar
Buenos Aires, Argentina
Active, not recruitingClínica Universitaria Reina Fabiola
Córdoba, Argentina
Active, not recruitingFundación CORI para la Investigación y Prevención del Cáncer
La Rioja, Argentina
Active, not recruitingCancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Active, not recruitingHenan Cancer Hospital
Zhengzhou, Henan, China
Active, not recruitingHubei Cancer Hospital
Wuhan, Hubei, China
Active, not recruitingThe First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Active, not recruitingSir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Active, not recruitingVseobecna fakultni nemocnice v Praze
Prague, Czechia
Active, not recruitingNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
Active, not recruitingCOI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Mexico City, Mexico
Active, not recruitingHospital MAC Periferico Sur
Mexico City, Mexico City, Mexico
Active, not recruitingINCAN
Mexico City, Mexico City, Mexico
Active, not recruitingHospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Active, not recruitingHospital Reforma
Oaxaca City, Oaxaca, Mexico
Active, not recruitingOaxaca Site Management Organization
Oaxaca City, Mexico
Active, not recruitingOnkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
Bratislava, Slovakia
Active, not recruitingNarodny onkologicky ustav
Bratislava, Slovakia
Active, not recruitingFakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia
Active, not recruitingCancer Research UK Edinburgh Centre
Edinburgh, Edinburgh, CITY of, United Kingdom
Active, not recruitingSt Bartholomew's Hospital
London, London, CITY of, United Kingdom
Active, not recruitingSarah Cannon Research Institute UK
London, United Kingdom
Active, not recruitingThe Christie Hospital NHS Foundation Trust
Manchester, United Kingdom
Active, not recruiting
Study team
Sponsor
Pfizer
Study ID C4391001
Study director
Pfizer CT.gov Call Center
Pfizer
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.