Phase 1a/1b Study of BG-C9074 for Advanced Solid Tumors
This study is testing a new treatment called BG-C9074, given through a vein (intravenous infusion), for people with advanced solid tumors. It will also look at BG-C9074 in combination with other cancer medicines, Tislelizumab and Bevacizumab. The main goals are to find out how safe BG-C9074 is, what side effects it might cause, and the best dose to use. Researchers will also check how the body handles the drug and if it shows any early signs of shrinking tumors. You might be able to join if you are 18 or older, have advanced, metastatic (spread), and unresectable (cannot be removed by surgery) solid tumors, and have already received standard treatments. This study is currently not recruiting, as its status is unclear.
- Study design
- This is a first-in-human study with a planned enrollment of 308 participants. It aims to find the right dose and expand testing to more participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured for approximately 3 years. The maximum tolerated dose and recommended dose will be determined over approximately 18 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
37 sites across 22 statesStudy leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
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What this trial measures
- 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-C9074Approximately 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 tislelizumabApproximately 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 tislelizumabApproximately 30 months
The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.