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
Terminated · Phase 1 · NCT06585488
Conditions: Metastatic Solid Tumors, Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Colorectal Cancer, Advanced Pancreatic Ductal Adenocarcinoma, Advanced Gastric Cancer, Advanced Gastroesophageal Junction Cancer, Advanced Esophageal Adenocarcinoma
At a glance
- Research payments reported, 2025
- $408,431
- U.S. investigators named
- 4
- Sites paid
- 4
- Planned or actual enrollment
- 47
About the trial
- Sponsor
- BeOne Medicines
- Tested
- BGB-53038 (drug), Tislelizumab (drug), Cetuximab (drug)
- Dates
- Started 2024-12-13; completion 2026-04-23
- Results posted
- Not yet
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 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.
From ClinicalTrials.gov, last updated 2026-07-08. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Beone Medicines USA, Inc. reported $408,431 in research payments for this study in 2025 (30 payments).
Products named: Tevimbra
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Anthony B. El-khoueiry, M.D. Medical Oncology · Los Angeles, CA
- Weijing Sun, MD Medical Oncology · Westwood, KS
- Nilofer S. Azad, MD Medical Oncology · Baltimore, MD
- David S. Hong, M.D. Medical Oncology · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Johns Hopkins University $128,807
- Ut MD Anderson Cancer Center $127,270
- University of Kansas Medical Center Research Institute, Inc. $83,255
- University of Southern California, Norris Comprehensive Cancer Center $69,100
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.