Tislelizumab: administered by intravenous infusion
Bevacizumab: administered by intravenous infusion
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
3. 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.
4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
5. Able to provide an archived tumor tissue sample.
6. Adequate bone marrow and organ function.
7. 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).
8. 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).
Exclusion Criteria:
1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.
2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
3. 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).
4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
5. Uncontrolled diabetes.
6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Approximately 3 years Number of participants with AEs and SAEs (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] Version \[v\] 5.0),, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074 — Approximately 18 months Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28% or the highest dose administered, respectively
Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074. — Approximately 18 months The potential RDFE(s) of BG-C9074 alone and in combination with tislelizumab will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available
Phase 1b: Overall Response Rate (ORR) as monotherapy and in combination with tislelizumab — Approximately 3 years ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074 as monotherapy and in combination with bevacizumab or tislelizumab — Approximately 30 months The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Trial sites (37)
Facility
City
Region
Status
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles
California
Recruiting
University of Colorado Cancer Center
Aurora
Colorado
Recruiting
Florida Cancer Specialist Research Institute Lake Nona
Orlando
Florida
Recruiting
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore
Maryland
Recruiting
James Cancer Hospital and Solove Research Institute
Columbus
Ohio
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
Recruiting
Macquarie University
North Ryde
New South Wales
Recruiting
Cancer Care Wollongong
Wollongong
New South Wales
Recruiting
Princess Alexandra Hospital
Woolloongabba
Queensland
Recruiting
Monash Health
Clayton
Victoria
Recruiting
Cabrini Hospital Malvern
Malvern
Victoria
Recruiting
Peter Maccallum Cancer Centre
Melbourne
Victoria
Recruiting
Linear Clinical Research
Nedlands
Western Australia
Completed
Hospital Sirio Libanes Brasilia
Brasília
Brazil
Recruiting
Liga Norte Riograndene Contra O Cancer
Natal
Brazil
Recruiting
Hospital Sao Lucas Da Pucrs
Porto Alegre
Brazil
Recruiting
Instituto Nacional de Cancer Hospital Do Cancer Ii
Rio de Janerio
Brazil
Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto
Brazil
Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo
Brazil
Recruiting
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo
Brazil
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Active Not Recruiting
Sun Yat Sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
The Second Hospital of Dalian Medical University
Dalian
Liaoning
Recruiting
Shengjing Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Liaoning Cancer Hospital and Institute
Shenyang
Liaoning
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Affiliated Hospital of Jining Medical University
Jining
Shandong
Recruiting
Weifang Peoples Hospital
Weifang
Shandong
Recruiting
Obstetrics and Gynecology Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
Tianjin Medical University Cancer Institute and Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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