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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06625775 | Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors | PHASE1 | RECRUITING | 392 | — | — | Oct 29, 2024 | Nov 1, 2028 | Apr 13, 2026 | 36 | United States, Australia +2 |
| 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...