Tests new drug BBO-10203 in adults with advanced solid tumors
Tests new drug BBO-10203 in adults with advanced cancers, including breast cancer.
Plain-language title generated from the registry record
Registry title: Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Key facts
- Where
- Barcelona, Lleida, Madrid, Pozuelo de Alarcón, and Valencia, SpainSee the 9 sites
- Phase
- Phase 1
Where in Spain
- Hospital Universitario Vall d'HebronBarcelona, SpainTaking people
- IOB Institute of Oncology - Hospital Quironsalud BarcelonaBarcelona, SpainTaking people
- START Barcelona - HM Nou Delfos HospitalBarcelona, SpainTaking people
- Hospital Universitari Arnau de VilanovaLleida, SpainTaking people
- Hospital Beata María AnaMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Quiron Madrid - NEXT OncologyPozuelo de Alarcón, SpainTaking people
- Hospital Universitari i Politécnic La FeValencia, SpainTaking people
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?
Trial details
- Who runs it
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Trial code
- NCT06625775EU 2024-519445-29-00
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.