Open
Actively Recruiting
Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
About
Brief Summary
A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Histologically documented locally advanced 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 2a 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
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Study Stats
Protocol No.
24-5129
Category
Lung Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica