Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Recruiting · NCT06625775 · Interventional (participants receive a specific treatment) · Lead sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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-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
Exclusion criteria
- 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
- ther inclusion/exclusion criteria are specified in the protocol
Where it is running
60 locations listed across 10 US states.
- City of Hope Comprehensive Cancer Center - Duarte, California, United States
- City of Hope Comprehensive Cancer Center - Duarte, California, United States
- University of California Los Angeles - Los Angeles, California, United States
- University of California Los Angeles - Los Angeles, California, United States
- University of California San Diego Moores Cancer Center - San Diego, California, United States
- University of California San Diego Moores Cancer Center - San Diego, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco, California, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Indiana University Simon Comprehensive Cancer Center - Indianapolis, Indiana, United States
- Indiana University Simon Comprehensive Cancer Center - Indianapolis, Indiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Insitute - Boston, Massachusetts, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Insitute - Boston, Massachusetts, United States
- St. Lukes Hospital of Kansas City - Kansas City, Missouri, United States
- St. Lukes Hospital of Kansas City - Kansas City, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Columbia University Irving Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Columbia University Irving Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- SCRI at Mary Crowley - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- SCRI at Mary Crowley - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- University of Texas San Antonio (UTSA) - San Antonio, Texas, United States
- University of Texas San Antonio (UTSA) - San Antonio, Texas, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Wisconsin Institute for Medical Research - Madison, Wisconsin, United States
- Wisconsin Institute for Medical Research - Madison, Wisconsin, United States
- IOB Institute of Oncology - Hospital Quironsalud Barcelona - Barcelona, Spain
- START Barcelona - HM Nou Delfos Hospital - Barcelona, Spain
- IOB Institute of Oncology - Hospital Quironsalud Barcelona - Barcelona, Spain
- START Barcelona - HM Nou Delfos Hospital - Barcelona, Spain
- Institut Bergonie - Bordeaux, France
- Institut Bergonie - Bordeaux, France
- Hospital Universitari Arnau de Vilanova - Lleida, Spain
- Hospital Universitari Arnau de Vilanova - Lleida, Spain
- Centre Léon Bérard - Lyon, France
- Centre Léon Bérard - Lyon, France
- Hospital Universitario Fundación Jiménez Díaz - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Seoul National University Hospital - Seoul, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Hospital Universitari i Politècnic La Fe - Valencia, Spain
- Hospital Universitari i Politècnic La Fe - Valencia, Spain
- Hospital Universitario Vall d'Hebron - Barcelona, Catalonia, Spain
- Hospital Universitario Vall d'Hebron - Barcelona, Catalonia, Spain
- Hospital Beata Maria Ana - Madrid, Madrid, Spain
- Hospital Beata Maria Ana - Madrid, Madrid, Spain
Showing 60 of 88 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →