Approval Probability
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ML Risk
BBO-11818 · 1 trial · 14 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1a - Dose Escalation Monotherapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 as monotherapy |
| Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) |
| Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV) |
| Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV) |
| Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) |
| Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) |
| Cohort 1g - Dose Escalation Combination Therapy (Cetuximab) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) |
| Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) |
| Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) |
| Cohort 1j - Dose Escalation Combination Therapy (BBO-10203) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 |
| Cohort 2a - Dose Expansion Monotherapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 as monotherapy |
| Cohort 2b - Dose Expansion Combination (Pembrolizumab) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) |
| Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV) |
| Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV) |
| Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) |
| Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) |
| Cohort 2g - Dose Expansion Combination Therapy (Cetuximab) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) |
| Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) |
| Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) |
| Cohort 2j - Dose Expansion Combination Therapy (BBO-10203) | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 |
| Name | Type | Description |
|---|---|---|
| BBO-11818 | DRUG | Participants will receive assigned dose of BBO-11818 orally (PO) |
| Pembrolizumab | DRUG | Patients will receive IV pembrolizumab |
| Platinum chemotherapy (cisplatin or carboplatin) | DRUG | Patients will receive IV platinum chemotherapy (cisplatin or carboplatin) |
| Pemetrexed | DRUG | Patients will receive IV pemetrexed |
| Cetuximab | DRUG | Patients will receive IV cetuximab |
| mFOLFOX6 | DRUG | Patients may receive IV mFOLFOX6 |
| BBO-10203 | DRUG | Participants will receive BBO-10203 orally (PO) |
| mFOLFIRINOX | DRUG | Patients will receive IV mFOLFIRINOX |
| Gemcitabine | DRUG | Patients will receive IV gemcitabine |
| Nab-paclitaxel | DRUG | Patients will receive IV nab-paclitaxel |
Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Lif...
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BBO-11818 is an investigational small molecule being developed for Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 1 clinical development and is being studied in adult subjects with KRAS mutant cancer, including NSCLC, pancreatic ductal adenocarcinoma, and colorectal cancer.
BBO-11818 targets KRAS, a protein that can drive tumor growth when mutated. It is being studied in cancers with specific KRAS mutations, including G12A, G12C, G12D, G12S, and G12V.
BBO-11818 is being developed by BridgeBio Oncology Therapeutics, Inc., which trades under the ticker BBOT. The company is conducting a Phase 1 clinical trial of BBO-11818 in adult subjects with KRAS mutant cancer.
BBO-11818 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants in the United States and Australia.
BBO-11818 is being studied in one active Phase 1 clinical trial, NCT06917079, titled "BBO-11818 in Adult Subjects With KRAS Mutant Cancer." The trial is recruiting up to 665 participants with KRAS-mutant cancers, including Non-Small Cell Lung Cancer, and is enrolling adults aged 18 years and older.