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 advanced solid tumors in adults. It is being developed as an oncology therapy by Kazia Therapeutics Limited. It has been evaluated in a Phase 1 clinical trial in patients with advanced solid tumors, and it is not an approved medicine.
EVT801 targets VEGFR3, a receptor. VEGFR3 is a receptor tyrosine kinase involved in lymphatic vessel signaling. By targeting this receptor, EVT801 is designed as a small molecule therapeutic candidate for advanced solid tumors in adults, and it has been studied in a Phase 1 trial.
EVT801 is being developed by Kazia Therapeutics Limited, which trades under the ticker KZIA. The company is advancing the small molecule as an oncology candidate for advanced solid tumors in adults. Development has reached Phase 1 clinical testing.
EVT801 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any indication. The Phase 1 program evaluated the small molecule in adults with advanced solid tumors, and the completed study enrolled 32 patients.
EVT801 has been studied in the Phase 1 trial NCT05114668, titled Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours. That trial enrolled 32 adults with advanced solid tumors, was conducted in France, and is now completed. No other trials of EVT801 are listed.
No, EVT801 is not approved. It is an investigational small molecule still in clinical development, having completed a Phase 1 trial in adults with advanced solid tumors. Kazia Therapeutics Limited is developing it, and further clinical evaluation would be needed before any regulatory approval could be considered.