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Study of BBO-10203 for Advanced Solid Tumors

This study is testing a new drug called BBO-10203 in people with advanced solid tumors, including certain types of breast cancer and colorectal cancer. Researchers want to find the safest and most effective dose of BBO-10203, both on its own and when given with other anti-cancer medicines like trastuzumab, fulvestrant, ribociclib, or FOLFOX. They will also look at how well BBO-10203 works against the cancer. You might be able to join if you have advanced breast cancer (HER2-positive or HR-positive/HER2-negative), or advanced colorectal or non-small cell lung cancer with a KRAS mutation. The study will measure side effects and how much of the drug stays in your body.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves a dose escalation phase to find the right dose, followed by an expansion phase, and plans to enroll 392 participants.
What's involved
Participants will receive BBO-10203 orally once daily. Other medications will be given as infusions, injections, or orally on specific schedules.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to approximately 5 years to monitor side effects and determine recommended doses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06625775

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
~392 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:BBO-10203TrastuzumabFulvestrantRibociclibFOLFOXBevacizumab

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent
Measured over Up to approximately 5 years
+2 more outcomes measured

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

Explore related trials

Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaSolid NeoplasmGTPase KRasPIK3CA Gene

Where it's being run

40 sites across 22 states
Spain6
California4
Texas4
Massachusetts2
Missouri2
New York2
Rio Grande do Sul2
São Paulo2

Who to contact

BBOT (BridgeBio Oncology Therapeutics)
[email protected]
650-405-8440
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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

What this trial measures

  • Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agentUp to approximately 5 years
  • Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)Up to approximately 5 years
  • Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumabUp to approximately 5 years