A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Summary
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
Description
This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. The study includes dose escalation phase and dose expansion phase
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
- DrugPembrolizumab
Patients will receive IV pembrolizumab
- DrugBBO-10203
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Locations (35)
- O'Neal Comprehensive Cancer Center at UABBirmingham, Alabama
- University of California - San Diego Moores Cancer CenterLa Jolla, California
- University of California San FranciscoSan Francisco, California
- UCLA Health - Santa Monica Cancer CareSanta Monica, California
- University of Colorado Cancer CenterAurora, Colorado
- Yale Cancer CenterNew Haven, Connecticut