A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations

Sponsor
BeOne Medicines
Study ID
NCT07746141
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • RAS Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BG-85738 — DRUG
    Administered orally
  • Tislelizumab — DRUG
    Administered intravenously
  • Cetuximab — DRUG
    Administered intravenously

Study Details

The purpose of this study is to test if the BG-85738 is safe and if it works in patients with advanced solid tumors with RAS mutations when it is given on its own and in combination.

Key Dates

First listed
Aug 4, 2026
Start date
Sep 4, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Part A- Monotherapy Dose escalation and safety
    Ascending dose levels of BG-85738 will be evaluated as monotherapy in participants with advanced or metastatic solid tumors with RAS mutations.
  • Experimental: Phase 1a: Part B - Combination therapy Dose escalation
    Sequential dose levels of BG-85738, selected based on Part A data, will be evaluated in combination with tislelizumab or in combination with cetuximab.
  • Experimental: Phase 1b: Part C- Monotherapy dose expansion
    Participants with selected tumor types will receive BG-85738 monotherapy at the RDFE(s) identified in Phase 1a Part A.
  • Experimental: Phase 1b: Part D - Combination therapy dose expansion
    Participants with select tumor types will receive BG-85738 in combination with tislelizumab or in combination with cetuximab at the RDFE(s) identified in Phase 1a Part B

Primary Outcome Measure

Phase 1a (Part A and Part B): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 24 months ]

Central Contacts

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