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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
NCT06585488 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Tislelizumab
- DRUG Cetuximab
- DRUG BGB-53038
Study Locations (17)
Seoul Teugbyeolsi
- Samsung Medical Center — GangnamGu
- Severance Hospital Yonsei University Health System — SeodaemunGu
- Seoul National University Hospital — Seoul
- Asan Medical Center — SongpaGu
Victoria
- Monash Health — Clayton
- Peter Maccallum Cancer Centre — Melbourne
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Beijing Cancer Hospital — Beijing
California
- Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles
Kansas
- University of Kansas Medical Center Research Institute — Kansas City
Maryland
- Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore
Texas
- The University of Texas Md Anderson Cancer Center — Houston
New South Wales
- Blacktown Cancer and Haematology Centre — Blacktown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06585488
The ClinicalTrials.gov registry entry for NCT06585488 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeiGene, which has 91 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Metastatic Solid Tumors appearing as the primary indexed condition, and to 3 interventions — of which Tislelizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06585488 reports 17 study locations spanning 12 distinct geographic areas — top geographies include Seoul Teugbyeolsi, Victoria, Beijing Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06585488 about?
NCT06585488 is a clinical study titled "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 har...
What is the current status of trial NCT06585488?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 514 participants. The study started on 2024-11-26. Estimated completion is 2026-12.
What conditions does trial NCT06585488 study?
This clinical trial studies the following conditions: Metastatic Solid Tumors, Advanced Colorectal Cancer, Advanced Pancreatic Ductal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Advanced Non-squamous Non-small-cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06585488?
The interventions under investigation include: Tislelizumab (DRUG), Cetuximab (DRUG), BGB-53038 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06585488?
This trial is sponsored by BeiGene, which has 91 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06585488 being conducted?
This trial has 17 study locations across California, Kansas, Maryland, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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