A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phas

Trial Details

NCT ID
NCT06585488
Phase
PHASE1
Sponsor
BeiGene
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • BGB-53038
  • Tislelizumab
  • Cetuximab
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Houston, Texas, United States|29.76328,-95.36327
  • Blacktown, New South Wales, Australia|-33.76667,150.91667

Key Eligibility Criteria

  • Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Participants must have evidence of a KRAS mutation or wild-type amplification (copy number ≥ 8) based on testing of either tumor tissue or liquid b…
  • Able to provide an archived tumor tissue sample or fresh biopsy sample.

For full eligibility, visit ClinicalTrials.gov.

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