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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
Sponsor: BeiGene
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
514
Start Date
2024-11-26
Completion Date
2026-12
Last Updated
2026-03-18
Healthy Volunteers
Yes
Conditions
Interventions
BGB-53038
Administered orally
Tislelizumab
administered by intravenous infusion
Cetuximab
administered by intravenous infusion
Locations (17)
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Auckland City Hospital
Auckland, New Zealand
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea