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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
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Contact
Cheyone Evans
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT06343402
For detailed technical eligibility, visit ClinicalTrials.gov.