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Clinical Trials in the USA / NCT06596473
Recruiting Phase 1

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

NCT06596473 · tracked via the Priya Life Science USA tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2024-10-03
Last updated
2026-09-14

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

BG-C477TislelizumabChemotherapy

BG-C477: Administered intravenously.

Tislelizumab: Administered intravenously.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
City of Hope Phoenix Cancer Center Goodyear Arizona Recruiting
City of Hope National Medical Center Duarte California Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
Yale University Yale Cancer Center New Haven Connecticut Recruiting
Osf Saint Francis Medical Center Peoria Illinois Recruiting
The University of Kansas Cancer Center Westwood Kansas Recruiting
University of Mississippi Medical Center (Ummc) Jackson Mississippi Recruiting
John Theurer Cancer Center Hackensack University Medical Center Hackensack New Jersey Recruiting
The University of Texas Md Anderson Cancer Center Houston Texas Recruiting
Texas Oncology Longview Longview Texas Recruiting
Blacktown Cancer and Haematology Centre Blacktown New South Wales Recruiting
Northern Beaches Hospital Frenchs Forest New South Wales Recruiting
Sunshine Coast University Private Hospital Birtinya Queensland Recruiting
Cancer Research South Australia Adelaide South Australia Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
One Clinical Research Nedlands Western Australia Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Beijing Chest Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Chongqing University Cancer Hospital Chongqing Chongqing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Sun Yat Sen University Cancer Center Guangzhou Guangdong Recruiting
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch Nanning Guangxi Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Jiamusi Cancer Hospital Jiamusi Heilongjiang Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
The First Affiliated Hospital of Nanchang University Branch Xianghu Nanchang Jiangxi Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
Jining No1 Peoples Hospital East Branch Jining Shandong Recruiting
Linyi Peoples Hospital Beicheng Branch Linyi Shandong Recruiting
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
Yunnan Cancer Hospital Kunming Yunnan Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Hangzhou Zhejiang Recruiting

+ 19 more sites — see the full list on the official registry below.

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 NCT06596473 on ClinicalTrials.gov ↗ ← All trials in the USA