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BBO-10203

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |BridgeBio Oncology Therapeutics, Inc.|Last Updated: Jun 23, 2026

Target and mechanism

Molecular targetPI3Kα
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment392

FDA Designations

No designations recorded

Clinical trial landscape

BBO-10203 · 1 trial · 11 indications

Phase 1 1
NCT06625775Open-Label Study of BBO-10203 in Subjects With Advanced Solid TumorsSolid Tumor, Adult
RECRUITING392 Analytics
PHASE1RECRUITING
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent
Up 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 + bevacizumab
Up to approximately 5 years

Secondary Endpoints

Clinical benefit rate (CBR) as assessed by RECIST v1.1.
Up to approximately 5 years
Duration of response (DOR) as assessed by RECIST v1.1.
Up to approximately 5 years
Progression-free survival (PFS) as assessed by RECIST v1.1
Up to approximately 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BBO-10203EXPERIMENTALParticipants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily as monotherapy. This cohort will enroll patients with HER2-positive advanced breast cancer, HR-positive HER2-negative advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.
BBO-10203 + TrastuzumabEXPERIMENTALParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with trastuzumab. This cohort will enroll patients with HER2-positive advanced breast cancer.
BBO-10203 + FulvestrantEXPERIMENTALParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
BBO10203 + Fulvestrant + RibociclibEXPERIMENTALParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant and ribociclib as determined in the dose escalation. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
BBO10203 + FOLFOX + BevacizumabEXPERIMENTALParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with FOLFOX and bevacizumab. This cohort will enroll patients with KRAS-mutant advanced colorectal cancer.

Interventions

NameTypeDescription
BBO-10203DRUGParticipants will receive assigned dose of BBO-10203 orally once daily
TrastuzumabDRUGParticipants will receive trastuzumab as infusion or subcutaneous injection every 21 days
FulvestrantDRUGPatients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
RibociclibDRUGPatients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
FOLFOXDRUGPatients will receive FOLFOX as infusion every 14 days
BevacizumabDRUGPatients will receive bevacizumab as infusion every 28 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * 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 RECI...

Countries:United StatesAustraliaBrazilFranceSpain
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Recent Changes (Last 90 Days)

LOWJun 23, 2026NCT06625775lastUpdatePostDate: changed
LOWJun 23, 2026NCT06625775lastUpdatePostDate: changed

Frequently asked questions about BBO-10203

What is BBO-10203 used for?

BBO-10203 is an investigational small molecule being developed for the treatment of advanced solid tumors in adults. It is currently in Phase 1 clinical development for conditions including metastatic breast cancer, metastatic lung cancer, metastatic colorectal cancer, and other advanced solid tumors.

What does BBO-10203 target?

BBO-10203 targets PI3Kα, a protein involved in cell growth and survival pathways. By inhibiting this target, the drug aims to interfere with tumor cell proliferation in advanced solid tumors.

Who is developing BBO-10203?

BBO-10203 is being developed by BridgeBio Oncology Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is BBO-10203 in?

BBO-10203 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy.

What clinical trials is BBO-10203 in?

BBO-10203 is being studied in an open-label Phase 1 clinical trial with the identifier NCT06625775. This trial is recruiting approximately 392 participants with advanced solid tumors, including metastatic breast cancer, lung cancer, and colorectal cancer, across the United States, Australia, Brazil, France, and Spain.