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PI3K Inhibitor

BBO-10203 + Trastuzumab for Breast Cancer

Phase 1
Recruiting
Research Sponsored by TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial will be the first time testing a new drug called BBO-10203 in humans to see if it is safe and well-tolerated. They will also study how the drug moves through

Who is the study for?
This trial is for adults with certain advanced solid tumors: HER2-positive breast cancer, HR-positive/HER2-negative breast cancer, KRAS mutant colorectal or non-small cell lung cancer. Participants must have tried all standard treatments without success or be unsuitable for them due to tolerance issues. They should be relatively healthy (ECOG 0-1) and have a good heart function.
What is being tested?
The BREAKER-101 study tests BBO-10203 alone and combined with trastuzumab in patients with advanced solid tumors. It's the first time this drug is being tested in humans to see how safe it is, how well it's tolerated, and what happens to it inside the body.
What are the potential side effects?
As this is a first-in-human study of BBO-10203, specific side effects are unknown but may include typical reactions related to immune system activation such as fever, fatigue, nausea; infusion-related reactions; and potential impact on blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Combination Dose EscalationExperimental Treatment2 Interventions
Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) QD in combination with trastuzumab IV (8mg/kg over 90 minutes on Cycle 1 Day 1, 6mg/kg over 30-90 minutes during subsequent cycles)/SC (600mg). This cohort will enroll patients with advanced breast cancer.
Group II: Cohort 1b - BBO-10203 Combination Dose ExpansionExperimental Treatment2 Interventions
Participants enrolled in this cohort will receive BBO-10203 tablets orally QD in combination with trastuzumab IV (8mg/kg over 90 minutes on Cycle 1 Day 1, 6mg/kg over 30-90 minutes during subsequent cycles)/SC (600mg). This cohort will enroll patients with advanced breast cancer.
Group III: Cohort 1a - Monotherapy Dose Escalation/Cohort ExpansionExperimental Treatment1 Intervention
Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily (QD) as monotherapy. This cohort will enroll patients with advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

TheRas, Inc., d/b/a BridgeBio Oncology TherapeuticsLead Sponsor
1 Previous Clinical Trials
229 Total Patients Enrolled
~102 spots leftby Nov 2028
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