Testing a new KRAS inhibitor for advanced solid tumors
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
This study is testing a new drug for people with advanced solid tumors that have KRAS mutations to see if it’s safe and effective, both on its own and with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 514 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BeOne Medicines Industry-sponsored |
| Drugs / interventions | tislelizumab, cetuximab |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Trial ID | NCT06585488 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety and effectiveness of BGB-53038, a pan-KRAS inhibitor, in patients with advanced or metastatic solid tumors that have KRAS mutations or amplification. The study includes a dose escalation phase to determine the optimal dosage and a safety expansion phase. Additionally, it explores the use of BGB-53038 in combination with other treatments, such as tislelizumab for non-small cell lung cancer and cetuximab for colorectal cancer. Participants will be monitored for pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors that have confirmed KRAS mutations or wild-type amplification.
Not a fit: Patients without KRAS mutations or amplification, or those with other types of tumors not targeted by this treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat cancers associated with KRAS mutations.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities. 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: 1. Participants with tumors harboring KRAS G12R mutation. 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Los Angeles, California and 16 other locations
- Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California, United States (Recruiting)
- University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States (Recruiting)
- Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (Recruiting)
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Linear Clinical Research — Nedlands, Western Australia, Australia (Recruiting)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Samsung Medical Center — GangnamGu, Seoul Teugbyeolsi, South Korea (Recruiting)
- Severance Hospital Yonsei University Health System — SeodaemunGu, Seoul Teugbyeolsi, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Asan Medical Center — SongpaGu, Seoul Teugbyeolsi, South Korea (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beigene.com
- Phone: 1.877.828.5568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.