OncoMatch/Clinical Trials/NCT06625775
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Is NCT06625775 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for solid tumor, adult.
Treatment: BBO-10203 · Trastuzumab · Fulvestrant · Ribociclib · FOLFOX · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Tumor Agnostic
Breast Carcinoma
Colorectal Cancer
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2-positive advanced breast cancer
Required: ESR1 expression (HR-positive)
HR-positive/HER2-negative advanced breast cancer
Required: HER2 (ERBB2) wild-type (HER2-negative)
HR-positive/HER2-negative advanced breast cancer
Required: KRAS mutation
KRAS mutant advanced colorectal cancer (aCRC), KRAS mutant advanced non-small cell lung cancer (aNSCLC)
Required: PIK3CA mutation
confirmed PIK3CA mutation
Excluded: KRAS G12R
Patients with KRAS mutant aCRC who have KRAS G12R mutation [excluded]; Patients with KRAS mutant aNSCLC who have KRAS G12R mutation [excluded]
Excluded: BRAF V600E
BRAFV600E mutation [excluded]
Excluded: HER2 (ERBB2) amplification
HER2amp [excluded]
Excluded: MMR deficient
dMMR/MSI-H tumors [excluded]
Excluded: MSH2 MSI-H
dMMR/MSI-H tumors [excluded]
Excluded: EGFR mutation
tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Excluded: ALK fusion
tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Excluded: ROS1 fusion
tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Excluded: BRAF mutation
tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Excluded: RET fusion
tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Excluded: MET mutation
tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Excluded: EGFR exon 20 insertion
EGFR exon20 insertion
Excluded: NTRK1 fusion
NTRK
Excluded: NTRK2 fusion
NTRK
Excluded: NTRK3 fusion
NTRK
Excluded: HER2 (ERBB2) mutation
HER2
Disease stage
Metastatic disease required
Locally advanced and unresectable or metastatic ... Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-HER2-directed therapy — advanced breast cancer
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)
Must have received: standard of care — HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC
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
Must have received: CDK4/6 inhibitor — HR-positive, HER2-negative aBC (BBO-10203 + Fulvestrant combination cohort)
BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
Lab requirements
Cardiac function
adequate lvef assessed by echo or muga (bbo-10203 + trastuzumab cohorts only)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- University of California Los Angeles · Los Angeles, California
- University of California San Diego Moores Cancer Center · San Diego, California
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06625775 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-HER2-directed therapy and standard of care.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with KRAS alterations eligible?
No. KRAS G12R is an exclusion criterion.
Are patients with BRAF alterations eligible?
No. BRAF V600E is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify