Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EVT801 · 1 trial · 1 indication
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 ...
EVT801 is an investigational small molecule being studied for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development. The drug is being evaluated for its safety, tolerability, and pharmacokinetics in patients with advanced solid tumors.
EVT801 is being developed by Kazia Therapeutics Limited, an oncology-focused biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol KZIA. Kazia is conducting clinical trials to evaluate the drug's potential in treating solid tumors.
EVT801 is in Phase 1 clinical development. A Phase 1 trial has been completed to assess the drug's safety, tolerability, and pharmacokinetics in patients with advanced solid tumors. The drug is still investigational and has not been approved by regulatory authorities.
EVT801 has been studied in a Phase 1 clinical trial registered as NCT05114668. This trial, titled "Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours," was conducted in France and enrolled 32 adult patients. The trial has been completed.
Yes, EVT801 is a small molecule drug. It is being developed as an oncology treatment for solid tumors. The drug is administered to adult patients and is currently in Phase 1 clinical development, with one completed trial evaluating its safety and pharmacokinetics.