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NCT06233942PHASE1Recruiting

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

BeOne Medicines

Start Date

4/12/2024

Completion Date

5/15/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BG-C9074

DRUG

Tislelizumab

DRUG

Bevacizumab

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Conditions

Advanced Solid Tumor

Locations

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California 90089-1019

United States

University of Colorado Cancer Center

Aurora, Colorado 80045-2517

United States

Florida Cancer Specialist Research Institute Lake Nona

Orlando, Florida 32827-7400

United States

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland 21287

United States

James Cancer Hospital and Solove Research Institute

Columbus, Ohio 43210-1240

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Macquarie University

North Ryde, New South Wales NSW 2109

Australia

Cancer Care Wollongong

Wollongong, New South Wales NSW 2500

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland QLD 4102

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

Cabrini Hospital Malvern

Malvern, Victoria VIC 3144

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

Hospital Sirio Libanes Brasilia

Brasília, 70200-730

Brazil

Liga Norte Riograndene Contra O Cancer

Natal, 59062-000

Brazil

Hospital Sao Lucas Da Pucrs

Porto Alegre, 90610-000

Brazil

Instituto Nacional de Cancer Hospital Do Cancer Ii

Rio de Janerio, 20220-410

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, 01246-000

Brazil

Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria

São Paulo, 01318-001

Brazil

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong 510060

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei 430022

China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430030

China

The Second Hospital of Dalian Medical University

Dalian, Liaoning 116023

China

Shengjing Hospital of China Medical University

Shenyang, Liaoning 110004

China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning 110042

China

Qilu Hospital of Shandong University

Jinan, Shandong 250000

China

Affiliated Hospital of Jining Medical University

Jining, Shandong 272000

China

Weifang Peoples Hospital

Weifang, Shandong 261000

China

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality 200011

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310022

China

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo 135-8550

Japan