Study of BG-T187 for Advanced Solid Tumors
This study is testing a new drug called BG-T187, given under the skin, sometimes alone and sometimes with other cancer medicines given through a vein. It's for people with advanced solid tumors. The main goals are to see how safe BG-T187 is, what side effects it causes, and to find the best dose. Researchers will also look at how the body handles the drug and if it shows any early signs of fighting cancer. This is a first-time-in-human study, meaning it's the first time BG-T187 is being tested in people. You can join if you are 18 or older, can sign a consent form, and have a good performance status (meaning you are generally active and able to care for yourself). The study aims to enroll 153 participants, but its current status is unclear.
- Study design
- This is a Phase 1a/1b, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves dose escalation and expansion, and plans to enroll 153 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety and dosing information will be measured for approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
30 sites across 21 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 2 years
Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome \[CRS\] and immune effector cell associated neurotoxicity syndrome \[ICANS\]); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
- Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187Approximately 2 years
MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively.
- Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187Approximately 2 years
RDFE(s) is determined based on the MAD or MTD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available
- Phase 1b: Overall Response Rate (ORR)Approximately 2 years
ORR is defined as the percentage of participants with confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agentsApproximately 2 years
R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available