Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
BG-C9074: administered by intravenous infusion
Tislelizumab: administered by intravenous infusion
Bevacizumab: administered by intravenous infusion
Study 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
Primary outcome measure(s)
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Approximately 3 years
Number of participants with AEs and SAEs (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] Version \[v\] 5.0),, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria. - Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074 — Approximately 18 months
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28% or the highest dose administered, respectively - Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074. — Approximately 18 months
The potential RDFE(s) of BG-C9074 alone and in combination with tislelizumab will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available - Phase 1b: Overall Response Rate (ORR) as monotherapy and in combination with tislelizumab — Approximately 3 years
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1. - Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074 as monotherapy and in combination with bevacizumab or tislelizumab — Approximately 30 months
The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Usc Norris Comprehensive Cancer Center (Nccc) | Los Angeles | California | Recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | Recruiting |
| Florida Cancer Specialist Research Institute Lake Nona | Orlando | Florida | Recruiting |
| Sidney Kimmel Comprehensive Cancer At Johns Hopkins | Baltimore | Maryland | Recruiting |
| James Cancer Hospital and Solove Research Institute | Columbus | Ohio | Recruiting |
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | Recruiting |
| Macquarie University | North Ryde | New South Wales | Recruiting |
| Cancer Care Wollongong | Wollongong | New South Wales | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| Cabrini Hospital Malvern | Malvern | Victoria | Recruiting |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Completed |
| Hospital Sirio Libanes Brasilia | Brasília | Brazil | Recruiting |
| Liga Norte Riograndene Contra O Cancer | Natal | Brazil | Recruiting |
| Hospital Sao Lucas Da Pucrs | Porto Alegre | Brazil | Recruiting |
| Instituto Nacional de Cancer Hospital Do Cancer Ii | Rio de Janerio | Brazil | Recruiting |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto | São José do Rio Preto | Brazil | Recruiting |
| Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira | São Paulo | Brazil | Recruiting |
| Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria | São Paulo | Brazil | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | Recruiting |
| Fujian Cancer Hospital | Fuzhou | Fujian | Active Not Recruiting |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | Recruiting |
| Weifang Peoples Hospital | Weifang | Shandong | Recruiting |
| Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | Recruiting |
| National Cancer Center Hospital East | Kashiwa | Chiba | Active Not Recruiting |
| Cancer Institute Hospital of Jfcr | Kotoku | Tokyo | Active Not Recruiting |
On this site
📄 Avastin (bevacizumab) drug profile →More BeOne Medicines trials in Japan
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 NCT06233942 on ClinicalTrials.gov ↗ ← All trials in Japan