Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06917079 | BBO-11818 in Adult Subjects With KRAS Mutant Cancer | PHASE1 | RECRUITING | 665 | — | — | Mar 31, 2025 | Sep 1, 2029 | Jun 2, 2026 | 17 | United States, Australia |
| 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...