A Study of BG-C477 in Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) criteria. - Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) — Approximately 1 year
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. - Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477 — Approximately 1 year
RDFE of BG-C477 monotherapy will be determined based upon available data. - Phase 1b: Overall Response Rate (ORR) — Approximately 2 years
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. - Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477 — Approximately 2 years
RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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Other trials for the same condition
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