Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06596473

PHASE1

A Study of BG-C477 in Participants With Advanced Solid Tumors

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Official title: A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

310

Start Date

2024-10-03

Completion Date

2027-12-31

Last Updated

2026-05-26

Healthy Volunteers

Conditions

Advanced Solid Tumors

Interventions

DRUG

BG-C477

Administered intravenously.

DRUG

Tislelizumab

Administered intravenously.

DRUG

Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

Inclusion Criteria: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent * Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy * Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator * Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy * Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease * ≥ 1 measurable lesion as assessed by RECIST v1.1 * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 * Adequate organ function * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later. Exclusion Criteria: * Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload * History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics * Active leptomeningeal disease or uncontrolled, untreated brain metastasis * Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast) Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Locations (49)

City of Hope Phoenix Cancer Center

Goodyear, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Osf Saint Francis Medical Center

Peoria, Illinois, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Texas Oncology Longview

Longview, Texas, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

One Clinical Research

Nedlands, Western Australia, Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Jining No1 Peoples Hospital East Branch

Jining, Shandong, China

Linyi Peoples Hospital Beicheng Branch

Linyi, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan

Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

Kota Kinabalu Sabah, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, Malaysia

Auckland City Hospital

Auckland, New Zealand

Siriraj Hospital

Bangkok, Thailand

Clinical Research Directory

A Study of BG-C477 in Participants With Advanced Solid Tumors

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)