NCT06257758

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced or Metastatic Solid Tumors
• Breast Cancer
• Recurrent Ovarian Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	VIO-01	VIO-01 will be administered via intravenous infusion over a 60-minute period once weekly. Dosing will be according to body surface area. Based on emerging PK and PD data, alternative dosing schedules may be investigated during the Phase 1 part of the trial. If an alternative schedule is evaluated, the dose and schedule may not exceed the total dose already tested and cleared during the dose escalation. In Phase 2, participants will receive VIO-01 by intravenous infusion at RP2D and schedule determined during the phase 1 part of the study.

Timeline

• Start date: 2024-01-10
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-02-14
• Last updated: 2025-03-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study