Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT06625775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06625775
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 392 participants
Conditions and interventions
Conditions
- 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
Interventions
- BBO-10203 Drug
- Trastuzumab Drug
- Fulvestrant Drug
- Ribociclib Drug
- FOLFOX Drug
- Bevacizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2024
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Jun 22, 2026
2024 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Recruiting |
| University of California Los Angeles | Los Angeles | California | 90095 | Recruiting |
| University of California San Diego Moores Cancer Center | San Diego | California | 92093 | Recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Indiana University Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Dana-Farber Cancer Insitute | Boston | Massachusetts | 02215 | Recruiting |
| St. Lukes Hospital of Kansas City | Kansas City | Missouri | 64111 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| SCRI at Mary Crowley | Dallas | Texas | 75230 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| University of Texas San Antonio (UTSA) | San Antonio | Texas | 78229 | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
| Wisconsin Institute for Medical Research | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06625775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06625775 live on ClinicalTrials.gov.