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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
665
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
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
RECRUITINGUniversity of California Davis
Sacramento, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
San Diego, California, United States
RECRUITINGUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGOSF Healthcare Cancer Institute
Peoria, Illinois, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
RECRUITING...and 7 more locations
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: approximately 5 years
Determine recommended dose of BBO-11818 in combination with pembrolizumab ± cis/carboplatin + pemetrexed, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203
Time frame: approximately 5 years
Objective response rate (ORR) per RECIST v1.1 and CNS RECIST
Time frame: approximately 5 years
Clinical benefit rate (CBR) per RECIST v1.1
Time frame: approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: approximately 5 years
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: approximately 5 years
Overall Survival (OS)
Time frame: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax)
Time frame: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax)
Time frame: approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC)
Time frame: approximately 5 years
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
CONTACT
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