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Clinical Trial 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.


Clinical Trial Description

This is a phase 1/2 open-label, multicenter, basket study to determine the safety, anti-tumor activity, tolerability, and PK/PD of VIO-01 alone or in combination with other anti-cancer therapies in select participants with advanced HRRm or HRD+ solid tumors (i.e. BRCA1/2 mutated breast cancer, HRR mutated prostate cancer) or HRRm/HRD+/HRP (phase 1 only) recurrent ovarian cancer. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06257758
Study type Interventional
Source Valerio Therapeutics
Contact Lisa Fitzgerald
Phone 1-617-485-1458
Email l.fitzgerald@valeriotx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date January 10, 2024
Completion date December 28, 2028

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