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A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplifications

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Trial Profile

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplifications

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Aug 2025

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At a glance

  • Drugs BGB 53038 (Primary) ; Cetuximab (Primary) ; Tislelizumab (Primary)
  • Indications Colorectal cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors BeOne Medicines

Most Recent Events

  • 10 Jul 2025 Planned number of patients changed from 177 to 514.
  • 27 Feb 2025 According to BeiGene media release, data readout is anticipated in first half of 2025.
  • 13 Dec 2024 Status changed from not yet recruiting to recruiting.

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