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BBO-10203 · 1 trial · 11 indications
| Arm | Type | Description |
|---|---|---|
| BBO-10203 | EXPERIMENTAL | Participants 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 + Trastuzumab | EXPERIMENTAL | Participants 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 + Fulvestrant | EXPERIMENTAL | Participants 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 + Ribociclib | EXPERIMENTAL | Participants 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 + Bevacizumab | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| BBO-10203 | DRUG | Participants will receive assigned dose of BBO-10203 orally once daily |
| Trastuzumab | DRUG | Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days |
| Fulvestrant | DRUG | Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15) |
| Ribociclib | DRUG | Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off) |
| FOLFOX | DRUG | Patients will receive FOLFOX as infusion every 14 days |
| Bevacizumab | DRUG | Patients will receive bevacizumab as infusion every 28 days |
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...
BBO-10203 is an investigational small molecule drug being developed by BridgeBio Oncology Therapeutics, Inc. for the treatment of advanced solid tumors in adults. It is a biomarker-selected therapy, meaning trial enrollment focuses on patients whose tumors carry specific molecular features. It is currently in Phase 1 clinical development and has not been approved by the FDA.
BBO-10203 is being studied for advanced solid tumors in adults, including metastatic breast cancer, HER2-positive and HER2-mutant tumors, KRAS mutant metastatic colorectal cancer, metastatic lung cancer, and HR-positive, HER2-negative advanced breast cancer. It is investigational and has not been approved for any indication.
BBO-10203 targets PI3K alpha, a protein in the PI3K signaling pathway. By acting on this molecular target, the drug is designed to interfere with signaling that drives tumor growth. It is a small molecule developed as a biomarker-selected therapy, so trial enrollment is guided by tumor molecular characteristics.
BBO-10203 is being developed by BridgeBio Oncology Therapeutics, Inc., which trades under the ticker BBOT. The company is running the clinical program for the drug in advanced solid tumors.
BBO-10203 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program consists of one active, recruiting trial evaluating the drug in adults with advanced solid tumors.
BBO-10203 is being evaluated in the open-label Phase 1 study NCT06625775, titled an Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors. The trial is recruiting and plans to enroll 392 participants across the United States, Australia, Brazil, France, South Korea, and Spain. It enrolls adults aged 18 years and older.