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

February 5, 2024 updated by: Valerio Therapeutics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 (eg, BRCA1/2 mutated breast cancer, HRD+ ovarian cancer, HRR mutated prostate cancer).

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants must have measurable disease per RECIST 1.1

  2. Participants with select HRRm or HRD+ (by locally available results) locally advanced and/or metastatic solid tumors that have had disease progression after treatment with available therapies known to confer clinical benefit or who are intolerant, refractory to or ineligible for standard treatment such as:

    1. BRCA1/2 mutated breast cancer.
    2. HRD+ ovarian cancer.
    3. HRR mutated prostate cancer.
    4. Select HRRm or HRD+ solid tumors with Medical Monitor approval.

  3. For Participants with metastatic breast cancer:

    1. Histologically or cytologically confirmed recurrent or relapsed breast cancer.
    2. Advanced stage metastatic disease as documented by imaging.
    3. Participants must have documented status of ER, PR, and HER2 according to American Society of Clinical Oncology, College of American Pathologists (ASCO-CAP) criteria prior to study entry. Participants must have had a biopsy to confirm hormone receptor status in the metastatic setting prior to study entry. Participants with HER2 positive disease are not eligible for enrollment.
    4. Participants with hormone receptor-positive (estrogen and/or progesterone receptor-positive) disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic) or have disease that the treating physician believes to be inappropriate for endocrine therapy. Endocrine therapy must have been completed at least 7 days before study treatment.
    5. Participants with ER+ tumors should have progressed on prior CDK4/6 inhibitors (in addition to hormonal therapy) to be eligible.
    6. Participants with triple negative breast cancer (TNBC) should have received sacituzumab prior to study enrollment.
  4. Willingness to provide pre-treatment and on-treatment biopsies.

Participant Exclusion Criteria

The following criteria must be checked at the time of screening and at baseline. If ANY exclusion criterion applies, the participant must not be included in the study:

  1. Phase 2 Only: Have received more than one prior line of therapy in metastatic setting.

    Note: Phase 1 has no limits for prior lines of therapy.

  2. Participants with neurologic disorders such as Guillain-Barré syndrome (GBS), myasthenia gravis (MG), Parkinson's disease, amyotrophic lateral sclerosis (ALS), seizure disorder, multiple sclerosis (MS), or other chronic neurologic condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Dose escalation: Multiple dose levels of VIO-01 will be administered via intravenous infusion over a 60-minute period once weekly.
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.
Experimental: Dose Expansion HRRm or HRD+ Solid Tumors
Participants with advanced HRRm or HRD+ solid tumors will be administered recommended Phase 2 dose of VIO-01 via intravenous infusion over a 60-minute period once weekly.
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.
Experimental: Dose Expansion HRRm or HRD+ Ovarian Cancer
Participants with advanced HRRm or HRD+ ovarian cancer will be administered recommended Phase 2 dose of VIO-01via intravenous infusion over a 60-minute period once weekly.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Dose Limiting Toxicities
Time Frame: Baseline to 12 months
As measured by adverse events observed
Baseline to 12 months
Phase 2: Objective Response Rate (ORR)
Time Frame: Baseline to 12 months
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.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Assess the pharmacokinetics (PK) of VIO-01
Time Frame: Baseline to 12 months
Safety PK parameters: total exposure including area under the concentration-time curve from dosing (time 0) to 24hrs post dosing (AUC)0-24.
Baseline to 12 months
Phase 1: Assess the pharmacokinetics (PK) of VIO-01
Time Frame: Baseline to 12 months
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)
Baseline to 12 months
Phase 1: Assess the pharmacokinetics (PK) of VIO-01
Time Frame: Baseline to 12 months
Safety PK parameters: total exposure including Peak Plasma Concentration (Cmax).
Baseline to 12 months
Phase 2: Duration of response (DOR)
Time Frame: Baseline to 12 months
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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valerio Therapeutics

Investigators

  • Principal Investigator: Alexander Philipovskiy, M.D., PhD, Florida Cancer Specialists & Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

January 29, 2026

Study Completion (Estimated)

December 28, 2028

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIO-01-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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