A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
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-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
Description
This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab +/- cis/carboplatin + pemetrexed, cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. 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 NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Malignancy within the last 2 years as specified in the protocol * Untreated brain metastases * Known hypersensitivity to BBO-11818 or its excipients Other inclusion/exclusion criteria are specified in the protocol.
Interventions
- DrugBBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
- DrugPembrolizumab
Patients will receive IV pembrolizumab
- DrugPlatinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
- DrugPemetrexed
Patients will receive IV pemetrexed
- DrugCetuximab
Patients will receive IV cetuximab
- DrugFOLFOX
Patients will receive IV FOLFOX
- DrugNALIRIFOX
Locations (11)
- The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, California
- University of California San Diego Moores Cancer CenterSan Diego, California
- Moffitt Cancer CenterTampa, Florida
- Massachusetts General HospitalBoston, Massachusetts
- NYU Langone HealthNew York, New York
- Columbia University Irving Medical CenterNew York, New York