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Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours

NCT05114668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-02

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.

The study comprises two stages, each with distinct purposes, patient populations, and procedures:

* Stage 1: a multiple ascending dose escalation of EVT801 to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D in subjects with advanced solid tumours.
* Stage 2: a biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

EVT801

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.

Sponsors & Collaborators

  • Kazia Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Carlos Gomez-Roca, MD · Institut Claudius Regaud, Toulouse, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2024-11-04
Completion
2024-11-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114668 on ClinicalTrials.gov