First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
Participants will receive assigned dose of BBO-10203 orally once daily
Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
Patients will receive FOLFOX as infusion every 14 days
Patients will receive bevacizumab as infusion every 28 days
University of California Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
San Diego, California, United States
RECRUITINGUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent
Time frame: Up to approximately 5 years
Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: Up to approximately 5 years
Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab
Time frame: Up to approximately 5 years
Clinical benefit rate (CBR) as assessed by RECIST v1.1.
Time frame: Up to approximately 5 years
Duration of response (DOR) as assessed by RECIST v1.1.
Time frame: Up to approximately 5 years
Progression-free survival (PFS) as assessed by RECIST v1.1
Time frame: Up to approximately 5 years
Overall survival (OS)
Time frame: Up to approximately 5 years
Area under the concentration-time curve (AUC
Time frame: Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Maximum plasma drug concentration (Cmax)
Time frame: Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Time for maximum plasma drug concentration (Tmax)
Time frame: Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Objective response rate (ORR) as assessed by RECIST v1.1 for patients with measurable disease
Time frame: Up to approximately 5 years
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Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Insitute
Boston, Massachusetts, United States
RECRUITINGSt. Lukes Hospital of Kansas City
Kansas City, Missouri, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
RECRUITING...and 17 more locations