Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) (Voir sur ClinicalTrials)
octobre 2024
novembre 2028
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 10/06/2026 11:15:07 | Contacter | ||
Critères
Tous
- 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
Other inclusion/exclusion criteria are specified in the protocol