Tests new drug BBO-10203 in adults with advanced solid tumors
Tests new drug BBO-10203 in adults with advanced cancers, including breast cancer.
Key facts
- Who runs it
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Where
- Bordeaux, Lyon, Montpellier, Saint-Cloud, Saint-Herblain, and Villejuif, FranceSee the 6 sitesAlso in 5 other countries, 38 sites
- Trial code
- Registry title
- Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 392 people, planned
- Started
- 29 Oct 2024
- Expected to end
- Nov 2028
- Type of study
- Interventional, 5 groups
- Treatments tested
- BBO-10203
- Trastuzumab
- Fulvestrant
- Ribociclib
- FOLFOX
- Bevacizumab
- Record updated
- 1 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced HER2-positive or HR-positive/HER2-negative breast cancer, or advanced colorectal or lung cancer with a KRAS mutation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced and unresectable, or metastatic disease. Measurable disease by RECIST v1.1 is needed, except that bone-only disease is permitted in HR-positive, HER2-negative breast cancer. ECOG performance status 0-1.
- Earlier treatment
- HER2-positive breast cancer: at least 2 prior lines of anti-HER2 therapy (1 is enough if no other standard of care is available in the region). Other single-drug cohorts: progression on or recurrence after at least one line of standard treatment. Fulvestrant cohort: must have had a CDK4/6 inhibitor. Fulvestrant + ribociclib cohort: no prior systemic therapy for advanced disease. FOLFOX cohort: one prior irinotecan-containing line is allowed but not required.
- Biomarker or test result
- Colorectal and lung cancer: KRAS mutation. Breast cancer in the fulvestrant cohorts: confirmed PIK3CA mutation. HER2-positive breast cancer for the HER2 cohorts.
Main reasons for not taking part
- KRAS G12R mutation in colorectal or lung cancer
- BRAFV600E mutation, HER2 amplification or dMMR/MSI-H tumors in colorectal cancer
- Other targetable driver mutations in lung cancer (for example EGFR, ALK, ROS1, BRAF, RET, MET, NTRK, HER2)
- Untreated or non-stable brain metastases
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
- Patients with untreated and/or non-stable brain metastases; Other inclusion/exclusion criteria are specified in the protocol
Where in France
Also in 5 other countries, 38 sites
- Institut BergonieBordeaux, FranceContact: BBOT (BridgeBio Oncology Therapeutics)Taking people
- Centre Leon BerardLyon, FranceContact: BBOT (BridgeBio Oncology Therapeutics)Taking people
- Institut régional du Cancer de Montpellier - Val d'AurelleMontpellier, FranceContact: BBOT (BridgeBio Oncology Therapeutics)Taking people
- Institut Curie - René-Huguenin HospitalSaint-Cloud, FranceContact: BBOT (BridgeBio Oncology Therapeutics)Taking people
- lnstitut de Cancérologie de l'Ouest - Site Saint-HerblainSaint-Herblain, FranceContact: BBOT (BridgeBio Oncology Therapeutics)Taking people
- Institut Gustave RoussyVillejuif, FranceContact: BBOT (BridgeBio Oncology Therapeutics)Taking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- BBO-10203Treatment being tested
Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily as monotherapy. This cohort will enroll patients with HER2-positive advanced breast cancer, HR-positive HER2-negative advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.
- BBO-10203 + TrastuzumabTreatment being tested
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with trastuzumab. This cohort will enroll patients with HER2-positive advanced breast cancer.
Treatment: BBO-10203 and Trastuzumab
- BBO-10203 + FulvestrantTreatment being tested
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
Treatment: BBO-10203, Fulvestrant, and Ribociclib
- BBO10203 + Fulvestrant + RibociclibTreatment being tested
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant and ribociclib as determined in the dose escalation. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
Treatment: BBO-10203, Fulvestrant, and Ribociclib
- BBO10203 + FOLFOX + BevacizumabTreatment being tested
Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with FOLFOX and bevacizumab. This cohort will enroll patients with KRAS-mutant advanced colorectal cancer.
Treatment: BBO-10203, FOLFOX, and Bevacizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Tests new drug BBO-10203 in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 October 2026