What this study is
The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors.
The main questions it aims to answer are:
- To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A)
- To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B)
- To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK)
- To evaluate if antibodies to the study drug develop (immunogenicity)
- To evaluate preliminary efficacy to the drug
- To correlate preliminary efficacy with mutations in a biomarker called EGFR
Participants will:
- Provide written informed consent
- Undergo screening tests to ensure they are eligible for study treatment
- Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment
- Be followed for progression every 3 months for up to 2 years
What's being tested
- CPO301
Intervention · DRUG
Administered by intravenous injection
Study details
- Official title
- A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO301, an EGFR-Targeting Antibody-Drug Conjugate, in Adult Patients With Advanced or Metastatic Solid Tumors
- Sponsor
- Conjupro Biotherapeutics, Inc.
- Conditions
- Cancer · Cancer, Lung
- Enrolling
- 132 people
- Starts
- 2023-06-06
- Est. completion
- 2027-08
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥18 years
- Patients with histologically confirmed locally advanced or metastatic solid tumors who have disease progression, intolerance to prior therapy, are ineligible for available therapies, or refuse standard of care therapy in the metastatic setting.
- In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer based on previous biopsy result.
- In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR mutations based on previous biopsy result and Cohort 2 will be patients with other cancer(s) suggested to have sensitivity to CPO301 in Part A.
- At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1
- ECOG performance status 0 or 1 at screening
- Life expectancy >12 weeks
You can't join if
- Known, active, or uncontrolled central nervous system (CNS) metastasis or carcinomatous meningitis.
- Has AEs due to previous anti-tumor treatments not recovered to ≤Grade 1 (except for alopecia; some tolerable chronic toxicities of Grade 2 may be excluded after consultation with the sponsor, as judged by the investigator) according to NCI-CTCAE v5.0.
- Any serious and/or uncontrolled concurrent illness that may interfere with study participation Prior therapy
- Received other investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study
- The time interval between the latest anti-tumor treatment and the first dose of the investigational drug meets the following requirements: Have received anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and other clinical investigational drugs within 4 weeks before the first dose of the investigational drug; have received oral fluoropyrimidines, small molecule targeted drugs within 2 weeks before the first dose of the investigational drug; have received palliative radiotherapy or local therapy within 2 weeks before the first dose of investigational drug.
- Had major surgery within 4 weeks before the first dose of the investigational drug in the study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
- Jacob Thomas, MD · Principal investigator
RecruitingHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
- Carlos R Becerra, MD · Principal investigator
RecruitingUCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
- Lee S. Rosen, MD · Principal investigator
RecruitingSarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, United States
- Gerald Falchook, MD, MS · Principal investigator
RecruitingAdventHealth Cancer Institute
Celebration, Florida, United States
- Guru P. Sonpavde, MD · Principal investigator
RecruitingFlorida Cancer Specialists
Sarasota, Florida, United States
- Manish Patel, MD · Principal investigator
RecruitingDartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
- Konstantin Dragnev, MD · Principal investigator
RecruitingFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
- Anshu Giri, MD · Principal investigator
RecruitingSCRI Oncology Partners
Nashville, Tennessee, United States
- Melissa L Johnson, MD · Principal investigator
RecruitingNEXT Dallas
Dallas, Texas, United States
- Shiraj Sen, MD · Contact
RecruitingNEXT Virginia
Fairfax, Virginia, United States
- Alex Spira, MD · Principal investigator
Recruiting
3 sites outside the US
Cross Cancer Institute
Edmonton, Alberta, Canada
- Quincy Chu, MD · Principal investigator
RecruitingJuravinski Cancer Centre
Hamilton, Ontario, Canada
- Rosalyn Juergens, MD, PhD · Principal investigator
RecruitingPrincess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada
- Laswson Eng, MD · Principal investigator
Recruiting
Study team
Sponsor
Conjupro Biotherapeutics, Inc.
Study ID CPO301-US-101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.