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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05827614 | Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications | PHASE1 | TERMINATED | 85 | — | — | Mar 24, 2023 | Mar 17, 2026 | Jun 8, 2026 | 16 | United States |
TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
The MTD and/or RP2D of BBI-355 as a single agent and in combination with erlotinib, futibatinib, or BBI-825 will be determined.
| Arm | Type | Description |
|---|---|---|
| Single Agent Dose Escalation | EXPERIMENTAL | Single agent BBI-355, administered orally in 28-day cycles |
| Single Agent Dose Expansion | EXPERIMENTAL | Single agent BBI-355, administered orally in 28-day cycles |
| Dose Escalation in Combination with EGFR Inhibitor | EXPERIMENTAL | Combination therapy of BBI-355 and EGFR inhibitor erlotinib, administered orally in 28-day cycles. |
| Dose Escalation in Combination with FGFR Inhibitor | EXPERIMENTAL | Combination therapy of BBI-355 and FGFR1-4 inhibitor futibatinib, administered orally in 28-day cycles. |
| Dose Escalation in Combination with RNR Inhibitor | EXPERIMENTAL | Combination therapy of BBI-355 and RNR Inhibitor BBI-825, administered orally in 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| BBI-355 | DRUG | Oral CHK1 inhibitor |
| Erlotinib | DRUG | EGFR Inhibitor |
| Futibatinib | DRUG | FGFR1-4 Inhibitor |
| BBI-825 | DRUG | Oral RNR Inhibitor |
Key Inclusion Criteria: * Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists, * Evidence of oncogene amplification, * Availability of FFPE tumor tissue, archi...