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
NCT ID: NCT06585488
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
514 participants
INTERVENTIONAL
2024-11-26
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1a: Part A (Monotherapy Dose Escalation)
Sequential cohorts will be evaluated to determine the Recommended Dose for Expansion (RDFE) of BGB-53038 as a monotherapy.
BGB-53038
Administered orally
Phase 1a: Part B (Monotherapy Safety Expansion)
Participants will be enrolled at dose levels determined in Part A with the Safety Monitoring Committee to confirm the final RDFE(s) for BGB-53038 monotherapy.
BGB-53038
Administered orally
Phase 1a: Part C (Combination Therapy Dose Escalation)
Sequential cohorts with increasing doses will be evaluated to determine the RDFE(s) for BGB-53038 in combination with tislelizumab or cetuximab.
BGB-53038
Administered orally
Tislelizumab
administered by intravenous infusion
Cetuximab
administered by intravenous infusion
Phase 1b: Part D (Monotherapy Dose Expansion)
Participants will be enrolled to receive the RDFE(s) of BGB-53038 monotherapy
BGB-53038
Administered orally
Phase 1b: Part E (Combination Therapy Dose Expansion)
Participants will be enrolled to receive BGB-53038 at the RDFE(s) as determined in Part C of Phase 1a in combination with tislelizumab and in combination with cetuximab, respectively.
BGB-53038
Administered orally
Tislelizumab
administered by intravenous infusion
Cetuximab
administered by intravenous infusion
Interventions
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BGB-53038
Administered orally
Tislelizumab
administered by intravenous infusion
Cetuximab
administered by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
3. 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
4. Able to provide an archived tumor tissue sample or fresh biopsy sample.
5. ≥ 1 measurable lesion per RECIST v1.1.
6. Adequate organ function.
7. 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
8. 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).
Exclusion Criteria
2. 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
3. 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.
4. 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).
5. 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.
6. 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.
18 Years
ALL
Yes
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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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
BundangGu SeongnamSi, 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
Start Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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2024-514704-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-53038-101
Identifier Type: -
Identifier Source: org_study_id
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