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NCT06596473PHASE1Recruiting

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

BeOne Medicines

Start Date

10/3/2024

Completion Date

12/31/2027

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.

Detailed Description

This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents. Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BG-C477

DRUG

Tislelizumab

DRUG

Chemotherapy

Interested in This Trial?

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Conditions

Advanced Solid Tumors

Locations

City of Hope Phoenix Cancer Center

Goodyear, Arizona 85338

United States

City of Hope National Medical Center

Duarte, California 91010-3012

United States

University of Colorado Cancer Center

Aurora, Colorado 80045-2517

United States

Yale University Yale Cancer Center

New Haven, Connecticut 06520-8028

United States

Osf Saint Francis Medical Center

Peoria, Illinois 61637

United States

The University of Kansas Cancer Center

Westwood, Kansas 66205-2003

United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Texas Oncology Longview

Longview, Texas 75601

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Northern Beaches Hospital

Frenchs Forest, New South Wales NSW 2086

Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland QLD 4575

Australia

Cancer Research South Australia

Adelaide, South Australia SA 5000

Australia

The Alfred Hospital

Melbourne, Victoria VIC 3004

Australia

One Clinical Research

Nedlands, Western Australia WA 6009

Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality 101149

China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality 400030

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong 510060

China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong 510515

China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi 530201

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang 154004

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450052

China

Hubei Cancer Hospital

Wuhan, Hubei 430079

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

Jiangxi Cancer Hospital

Nanchang, Jiangxi 330029

China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi 332000

China

The First Hospital of China Medical University

Shenyang, Liaoning 110001

China

Jining No1 Peoples Hospital East Branch

Jining, Shandong 272002

China

Linyi Peoples Hospital Beicheng Branch

Linyi, Shandong 276005

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610041

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

Yunnan Cancer Hospital

Kunming, Yunnan 650100

China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang 310002

China

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang 317004

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Shizuoka Cancer Center

Suntogun, Shizuoka 411-8777

Japan

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Tokyo 113-8677

Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo 135-8550

Japan

Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

Kota Kinabalu Sabah, 88996

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

Sunway Medical Centre

Petaling Jaya, 47500

Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, 62250

Malaysia

Auckland City Hospital

Auckland, 1023

New Zealand

Siriraj Hospital

Bangkok, 10700

Thailand

Srinagarind Hospital (Khon Kaen University)

Muang, 40002

Thailand

King Chulalongkorn Memorial Hospital (Chulalongkorn University)

Pathum Wan, 10330

Thailand