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NCT06585488 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Metastatic Solid Tumors and Advanced Colorectal Cancer, sponsored by BeiGene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 514
- Enrollment target
- 17
- Study locations
NCT06585488: Recruiting Phase 1 study of Metastatic Solid Tumors and Advanced Colorectal Cancer, sponsored by BeiGene.
NCT06585488 is a Phase 1 study of Metastatic Solid Tumors and Advanced Colorectal Cancer that is actively recruiting participants, run by BeiGene. The registered enrollment target is 514 participants, above the 181-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (184% higher). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06585488, a Phase 1 study of Metastatic Solid Tumors and Advanced Colorectal Cancer, is actively recruiting participants, sponsored by BeiGene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 514 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCICTCAE\] Version \[v\] 5.0), timing, seriousness, and relationship to study drug(s); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
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 |
What NCT06585488 shows while recruiting
NCT06585488 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (184% higher).
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.
NCT06585488 lists 17 locations in 12 states (Seoul Teugbyeolsi, Victoria, Beijing Municipality).
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.
What interventions are being tested in trial NCT06585488?
The interventions under investigation include: Tislelizumab (DRUG), Cetuximab (DRUG), BGB-53038 (DRUG).
Who is sponsoring clinical trial NCT06585488?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
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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