Last updated 46 days ago
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
392 patients around the world
Available in United States, Brazil
This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
2Research sites
392Patients around the world
This study is for people with
Solid tumors
Breast Cancer
Colorectal cancer
Lung cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Futtura Oncologia - Porto Alegre
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
StudyBREAKER-101
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Study typeInterventional
Conditions
Solid tumorsBreast CancerColorectal cancerLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06625775
