Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

Drug: BG-T187: administered subcutaneously

Other Therapeutic Agents: administered intravenously

Study summary

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.

Eligibility

Primary outcome measure(s)

• 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-T187 — Approximately 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-T187 — Approximately 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 agents — Approximately 2 years
  R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available

Trial sites (34)

More BeOne Medicines trials in South Korea

Other trials for the same condition