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

Launched by BEIGENE · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BGB-53038, which is designed to target specific changes in cancer cells known as KRAS mutations. These changes can make certain types of cancers, like advanced lung, colorectal, pancreatic, gastric, and esophageal cancers, harder to treat. The trial aims to find out how safe and effective BGB-53038 is when given alone and when combined with other treatments for patients who have these specific cancers. The study has two parts: one focuses on finding the right dose and assessing safety, while the other looks at how well the drug works in a larger group of patients.

To participate in the trial, patients generally need to be between 18 and 75 years old, have a confirmed KRAS mutation, and meet certain health criteria. They must be willing to follow the study's requirements and provide a sample of their tumor tissue. Throughout the trial, participants will receive regular health check-ups and monitoring to ensure their safety. It's important to note that this trial is currently recruiting and is open to all genders. If you're interested or think you may qualify, discussing this with your doctor could be a helpful next step.

Gender

ALL

Eligibility 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.