What this study is
This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.
What's being tested
- BG-C9074
Intervention · DRUG
- Tislelizumab
Intervention · DRUG
- Bevacizumab
Intervention · DRUG
All interventions
administered by intravenous infusion
Study details
- Official title
- Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
- Sponsor
- BeOne Medicines
- Conditions
- Advanced Solid Tumor
- Enrolling
- 308 people
- Starts
- 2024-04-12
- Est. completion
- 2028-05-15
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.
- ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
- Able to provide an archived tumor tissue sample.
- Adequate bone marrow and organ function.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).
You can't join if
- Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
- Uncontrolled diabetes.
- Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (37)
33 openUsc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
RecruitingUniversity of Colorado Cancer Center
Aurora, Colorado, United States
RecruitingFlorida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States
RecruitingSidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States
RecruitingJames Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Recruiting
32 sites outside the US
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
RecruitingMacquarie University
North Ryde, New South Wales, Australia
RecruitingCancer Care Wollongong
Wollongong, New South Wales, Australia
RecruitingPrincess Alexandra Hospital
Woolloongabba, Queensland, Australia
RecruitingMonash Health
Clayton, Victoria, Australia
RecruitingCabrini Hospital Malvern
Malvern, Victoria, Australia
RecruitingPeter Maccallum Cancer Centre
Melbourne, Victoria, Australia
RecruitingHospital Sirio Libanes Brasilia
Brasília, Brazil
RecruitingLiga Norte Riograndene Contra O Cancer
Natal, Brazil
RecruitingHospital Sao Lucas Da Pucrs
Porto Alegre, Brazil
RecruitingInstituto Nacional de Cancer Hospital Do Cancer Ii
Rio de Janerio, Brazil
RecruitingFundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil
RecruitingIcesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil
RecruitingClinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, Brazil
RecruitingCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RecruitingSun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
RecruitingHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RecruitingUnion Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RecruitingTongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
RecruitingThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
RecruitingShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RecruitingLiaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
RecruitingQilu Hospital of Shandong University
Jinan, Shandong, China
RecruitingAffiliated Hospital of Jining Medical University
Jining, Shandong, China
RecruitingWeifang Peoples Hospital
Weifang, Shandong, China
RecruitingObstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RecruitingTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RecruitingZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RecruitingLinear Clinical Research
Nedlands, Western Australia, Australia
CompletedFujian Cancer Hospital
Fuzhou, Fujian, China
Active, not recruitingNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
Active, not recruitingCancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan
Active, not recruiting
Study team
Sponsor
BeOne Medicines
Study ID BG-C9074-101
Study director
Study Director
BeOne Medicines
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.