Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

Launched by THERAS, INC., D/B/A BBOT (BRIDGEBIO ONCOLOGY THERAPEUTICS) · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called BBO-8520 for adults with certain types of advanced cancer, specifically non-small cell lung cancer and colorectal cancer that have a specific change in their genes called the KRAS G12C mutation. The study aims to see how safe BBO-8520 is, how well it works, and how the body processes it when given alone or together with another medication called pembrolizumab.

To participate in this trial, patients need to have a confirmed diagnosis of advanced non-small cell lung cancer or colorectal cancer with the KRAS G12C mutation. They should also have measurable disease and a good performance status, meaning they are generally well enough to take part. However, certain patients, such as those with untreated brain cancer or specific allergies to the study drugs, may not be eligible. Participants will receive close monitoring and support throughout the trial, and their experiences will help researchers understand the potential of BBO-8520 as a new treatment option.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation
• • Measurable disease by RECIST v1.1
• • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Exclusion Criteria:
• • Patients with malignancy within the last 2 years as specified in the protocol
• • Patients with untreated brain metastases
• • Patients with known hypersensitivity to BBO-8520 or its excipients
• * For Cohorts 1b and 2b:
• • Patients with a known hypersensitivity to pembrolizumab or its excipients
• • Patients with active autoimmune disease of history of autoimmune disease that might recur
• • Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis
• • Other inclusion/exclusion criteria may apply