TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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.
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, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.
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 * Life expectancy \>24 weeks * Adequate organ function Exclusion Criteria: * Malignancy within the last 2 years as specified in the protocol * Untreated brain metastases Other inclusion/exclusion criteria are specified in the protocol.
Participants will receive assigned dose of BBO-11818 orally (PO)
Patients will receive IV pembrolizumab
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV pemetrexed
Patients will receive IV cetuximab
Patients may receive IV mFOLFOX6
Patients will receive IV mFOLFOX6
Participants will receive BBO-10203 orally (PO)
Patients will receive IV mFOLFIRINOX
Patients will receive IV gemcitabine
Patients will receive IV nab-paclitaxel