drugset / Trial / NCT06257758

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors

NCT06257758 ↗

Phase 1/2 Terminated 6 enrolled Valerio Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this phase 1/2 clinical trial is to investigate the safety of an investigational drug called VIO-01 when taken by people who have different types of solid tumor cancers. There are two parts to this trial, part 1 and part 2. Part 1 of the trial aims to answer these questions: * The safety and tolerability of VIO-01 when it is given alone or in combination with other anti-cancer therapies. * The highest dose that people can take without having unacceptable side effects * How well your body tolerates the drug alone or in combination, how they are absorbed, and the effects they have on your disease. Part 2 of the trial will further test VIO-01's effect in participants with advanced HRRm or HRD+ solid tumors and HRRm/HRD+ recurrent ovarian cancer. Participants will follow a schedule of visits to the study site to have assessments done related to their health condition and to receive the trial treatment.

Timeline

Start
2024-01-10
Primary completion
2025-01-01
Completion
2025-01-01

Outcome

Outcome not reported

Stopped (Business): “Business decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject VIO-01 Unknown — Intravenous