TerminatedPhase 1NCT06585488
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBGB-53038 and Tislelizumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 8, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?BeOne Medicines

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
BeOne Medicines
Interventions being studied
Drug: BGB-53038; Drug: Tislelizumab; Drug: Cetuximab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. Participants must have evidence of a KRAS mutation or wild-type amplification (copy number ≥ 8) based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by local laboratory 4. Able to provide an archived tumor tissue sample or fresh biopsy sample. 5. ≥ 1 measurable lesion per RECIST v1.1. 6. Adequate organ function. 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, for \> 7 days after the last dose of BGB-53038, \> 120 days after the last dose of tislelizumab, or \> 2 months after the last dose of cetuximab, whichever is later 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).

Reasons someone may not be able to joinExclusion criteria

1. Participants with tumors harboring KRAS G12R mutation. 2. Participants who have prior therapy with other anti-RAS treatment, including, but not limited to, therapy targeting specific KRAS allele mutation inhibitors, pan-KRAS inhibitors, and other pan-RAS inhibitors 3. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable CNS metastases are eligible, provided they meet select criteria. 4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 5. Participants with untreated chronic hepatitis B or chronic HBV carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening. Participants with active hepatitis C. 6. Participants with clinically significant infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment. Note: Other protocol defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Usc Norris Comprehensive Cancer Center (Nccc)Los Angeles, California
  • University of Kansas Medical Center Research InstituteKansas City, Kansas
  • Sidney Kimmel Comprehensive Cancer At Johns HopkinsBaltimore, Maryland
  • The University of Texas Md Anderson Cancer CenterHouston, Texas
  • Blacktown Cancer and Haematology CentreBlacktown, New South Wales
  • Monash HealthClayton, Victoria
  • Peter Maccallum Cancer CentreMelbourne, Victoria
  • Linear Clinical ResearchNedlands, Western Australia
  • Cancer Hospital Chinese Academy of Medical SciencesBeijing, Beijing Municipality
  • Beijing Cancer HospitalBeijing, Beijing Municipality
  • Shanxi Provincial Cancer HospitalTaiyuan, Shanxi
  • Auckland City HospitalAuckland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 8, 2026. Always confirm current availability with the study team.

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