Terminated
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
Led by BeOne Medicines · Updated on 2026-06-03
47
Participants Needed
17
Research Sites
N/A
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
Brief 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...
- Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- 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
- Able to provide an archived tumor tissue sample or fresh biopsy sample.
- ≥ 1 measurable lesion per RECIST v1.1.
- Adequate organ function.
- 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
- 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).
You will not qualify if you...
- Participants with tumors harboring KRAS G12R mutation.
- 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
- 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.
- 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).
- 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.
- 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/Exclusion criteria may apply.
Trial Site Locations
Total: 17 locations
1
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States, 90089-1019
Status Unknown
2
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160-8500
Status Unknown
3
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States, 21287
Status Unknown
4
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Status Unknown
5
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Status Unknown
6
Monash Health
Clayton, Victoria, Australia, VIC 3168
Status Unknown
7
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Status Unknown
8
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Status Unknown
9
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Status Unknown
10
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Status Unknown
11
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Status Unknown
12
Auckland City Hospital
Auckland, New Zealand, 1023
Status Unknown
13
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Status Unknown
14
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Status Unknown
15
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Status Unknown
16
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Status Unknown
17
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Status Unknown
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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