An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

BGB-58067: Planned doses administered on specified days per protocol.

BG-89894: Planned doses administered on specified days per protocol.

Standard of Care Therapy: Administered in accordance with relevant local guidelines and/or prescribing information.

Study summary

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Eligibility

Primary outcome measure(s)

• Phase 1a: Number of Participants with Adverse Events and Serious Adverse Events — From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 13 months)
  Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
• Phase 1a: Number of Participants with Adverse Events that meet Dose-Limiting Toxicity (DLT) criteria — Approximately 1 month
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy — Approximately 1 month
  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. Note: BGB-58067 + BG-89894 combination has been discontinued.
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy — Approximately 13 months
  RDFE of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be determined based upon the MTD or MAD. Note: BGB-58067 + BG-89894 combination has been discontinued.
• Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-58067 alone and in combination with standard of care therapy — Approximately 2 years
  RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.
• Phase 1b: Objective Response Rate (ORR) — Approximately 2 years
  ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.

Trial sites (101)

+ 61 more sites — see the full list on the official registry below.

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