Actively Recruiting
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
Led by BeiGene · Updated on 2026-03-18
514
Participants Needed
17
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow study requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Evidence of KRAS mutation or wild-type amplification (copy number ≥ 8) from tumor tissue or liquid biopsy
- Ability to provide archived tumor tissue or fresh biopsy sample
- At least one measurable lesion per RECIST v1.1 criteria
- Adequate organ function
- Females of childbearing potential agree to use effective birth control during the study and for specified periods after last dose of study drugs
- Non-sterile males agree to use effective birth control during treatment and for at least 4 months after last dose of study drugs
You will not qualify if you...
- Tumors with KRAS G12R mutation
- Prior therapy with anti-RAS treatments including KRAS allele mutation inhibitors, pan-KRAS inhibitors, or other pan-RAS inhibitors
- Active leptomeningeal disease or uncontrolled, untreated brain metastases; stable treated CNS metastases allowed with conditions
- Any malignancy within 2 years before first study treatment except the cancer under investigation or certain treated local cancers
- Untreated chronic hepatitis B or HBV carriers with high viral load; active hepatitis C
- Clinically significant infections requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days before first study treatment
- Other protocol-defined criteria may also apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States, 90089-1019
Actively Recruiting
2
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160-8500
Actively Recruiting
3
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
5
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
6
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
7
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Actively Recruiting
8
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
9
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
10
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
11
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
12
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
13
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
14
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
15
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
16
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
17
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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