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 +/- 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
387
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 will receive IV FOLFOX
Patients will receive IV NALIRIFOX
Patients will receive IV Gemcitabine
Patients will receive IV Nab-Paclitaxel
University of California San Diego Moores Cancer Center
San Diego, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, 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
RECRUITINGSarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGHuntsman Cancer Institute
Salt Lake City, Utah, United States
RECRUITINGIncidence 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, or cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel
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, irinotecan, and SN-38: Maximum blood concentration (Cmax)
Time frame: approximately 5 years
Pharmacokinetics of BBO-11818, irinotecan, and SN-38: Time to achieve Cmax (Tmax)
Time frame: approximately 5 years
Pharmacokinetics of BBO-11818, irinotecan, and SN-38: Area under the concentration-time curve (AUC)
Time frame: approximately 5 years
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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