Evaluating BBO-8520 for treating KRAS G12C non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BBO-8520, a direct inhibitor of KRAS G12C, both as a standalone treatment and in combination with pembrolizumab. The trial focuses on adult patients with locally advanced and unresectable or metastatic non-small cell lung cancer harboring the KRAS G12C mutation. It includes a dose escalation phase followed by a dose expansion phase to gather comprehensive data on the drug's performance.

Why it matters

Who can join: the full rules

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 or unstable 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

Where it's running

• O'Neal Comprehensive Cancer Center at UAB
  Birmingham, Alabama, United States Recruiting
• University of California - San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• UCLA Health - Santa Monica Cancer Care
  Santa Monica, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
• Email: onkoras-101ct.gov@bridgebiooncology.com
• Phone: 650-405-8440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.