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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05114668 | Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours | PHASE1 | COMPLETED | 32 | — | — | Nov 3, 2021 | Nov 22, 2024 | Sep 2, 2025 | 2 | France |
The MTD is defined as the highest dose administered at which fewer than one-third of patients experienced a DLT. The RP2D will be determined for Stage 1 on the basis of an overall assessment of safety, pharmacokinetics, and other information. The RP2D may be equal to, or lower than, the MTD.
To provide safety information for EVT801 by assessing adverse events, per CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Stage 1 | EXPERIMENTAL | \- Stage 1 (Dose Escalation Cohorts): Stage 1 is a multiple ascending dose escalation of EVT801 in patients with advanced solid tumours to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D for further investigation. |
| Stage 2 | EXPERIMENTAL | \- Stage 2 (Biomarker Expansion cohorts): A biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, will be recruited to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics. |
| Name | Type | Description |
|---|---|---|
| EVT801 | DRUG | Stage 1: Patients will be dosed orally with EVT801 capsules at the dose and schedule to which they are assigned. Stage 2: Patients will be dosed orally with EVT801 capsules at the MTD / RP2D identified in Stage 1 of the study. |
Inclusion Criteria: 1. Subjects of any gender who are ≥18 years of age at the time of study entry. 2. Histologically-confirmed advanced or metastatic solid tumours, unresponsive to standard treatment, or for whom no standard treatment is available or appropriate. 3. Measurable or evaluable disease ...