Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors, HER2-positive Metastatic Breast Cancer, KRAS Mutant Metastatic Colorectal Cancer, Metastatic Lung Cancer, Metastatic Colorectal Cancer, Advanced Lung Cancer, HR-positive, HER2-negative Advanced Breast Cancer, HER2-positive Advanced Breast Cancer

In brief

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.

Key facts

Study ID

NCT06625775

Run by

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

People needed

392

Starts

2024-10-29

Expected to finish

2028-11-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)
• Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy
• BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
• BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted
• BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required

You may not qualify if…

• Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
• Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
• Patients with untreated and/or non-stable brain metastases
• Other inclusion/exclusion criteria are specified in the protocol

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• University of California San Diego Moores Cancer Center — San Diego, California, United States (enrolling)
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Insitute — Boston, Massachusetts, United States (enrolling)
• St. Lukes Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• SCRI at Mary Crowley — Dallas, Texas, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Texas San Antonio (UTSA) — San Antonio, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Wisconsin Institute for Medical Research — Madison, Wisconsin, United States (enrolling)
• Scientia Clinical Research — Randwick, New South Wales, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• FUTTURA Oncologia — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Hospital São Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo, Brazil (enrolling)
• IEPE - Unimed Sorocaba — Sorocaba, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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