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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06777316 | A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 110 | — | — | Jan 22, 2025 | Jun 1, 2027 | Apr 17, 2026 | 13 | United States, Canada |
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters
Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters
| Arm | Type | Description |
|---|---|---|
| Phase 1: Dose Escalation | EXPERIMENTAL | Multiple doses of CGT4859 for oral administration |
| Phase 2: Signal Seeking | EXPERIMENTAL | Oral dose of CGT4859 at the RP2D as determined in Phase 1 |
| Name | Type | Description |
|---|---|---|
| CGT4859 | DRUG | CGT4859 is a selective FGFR2/3 inhibitor |
Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor. 2. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment. 3. Have measu...