A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Summary

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.

Description

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC) * Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only) * Stable brain metastases * Patients with HER2-pos…

Interventions

Drug
BBO-10203
Participants will receive assigned dose of BBO-10203 orally once daily
Drug
Trastuzumab
Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
Drug
Fulvestrant
Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
Drug
Ribociclib
Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
Drug
FOLFOX
Patients will receive FOLFOX as infusion every 14 days
Drug
Bevacizumab
Patients will receive bevacizumab as infusion every 28 days

Locations (36)

City of Hope Comprehensive Cancer Center
Duarte, California
University of California Los Angeles
Los Angeles, California
University of California San Diego Moores Cancer Center
San Diego, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California
Moffitt Cancer Center
Tampa, Florida
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana