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Clinical Trials in Australia / NCT06233942
Recruiting Phase 1

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

NCT06233942 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2024-04-12
Last updated
2026-09-16

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

BG-C9074Tislelizumab →Bevacizumab →

BG-C9074: administered by intravenous infusion

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)

Trial sites (37)

FacilityCityRegionStatus
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 Tianjin Tianjin Municipality Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting
National Cancer Center Hospital East Kashiwa Chiba Active Not Recruiting
Cancer Institute Hospital of Jfcr Kotoku Tokyo Active Not Recruiting

On this site

📄 Avastin (bevacizumab) drug profile →

More BeOne Medicines trials in Australia

Other trials for the same condition

Official registry record

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.

View NCT06233942 on ClinicalTrials.gov ↗ ← All trials in Australia