Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT06257758
Brief 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.
Detailed 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:
NCT06257758
Study Brief:
Protocol Section:
NCT06257758