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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States
Stephenson Cancer Center - University of Oklahoma
Oklahoma City, Oklahoma, United States
Next Oncology
San Antonio, Texas, United States
Phase 1: Dose Limiting Toxicities
As measured by adverse events observed
Time frame: Baseline to 12 months
Phase 2: Objective Response Rate (ORR)
Percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on Investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria guidelines.
Time frame: Baseline to 12 months
Phase 1: Assess the pharmacokinetics (PK) of VIO-01
Safety PK parameters: total exposure including area under the concentration-time curve from dosing (time 0) to 24hrs post dosing (AUC)0-24.
Time frame: Baseline to 12 months
Phase 1: Assess the pharmacokinetics (PK) of VIO-01
Safety PK parameters: total exposure including area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration (AUC0-last)
Time frame: Baseline to 12 months
Phase 1: Assess the pharmacokinetics (PK) of VIO-01
Safety PK parameters: total exposure including Peak Plasma Concentration (Cmax).
Time frame: Baseline to 12 months
Phase 2: Duration of response (DOR)
The time from earliest date of disease response (CR or PR) until earliest date of disease progression, or death, whichever occurs first, as assessed by Investigator using RECIST v1.1 criteria.
Time frame: Baseline to 12 months
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