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

Valerio Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer; Recurrent Ovarian Cancer; Advanced or Metastatic Solid Tumors; Prostate Cancer

Treatments: Drug: VIO-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06257758

VIO-01-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Participants must have measurable disease per RECIST 1.1

2. Participants with advanced and/or metastatic solid tumors showing select HRRM tumor alterations, or and HRD+ tumor score (as documented by local testing) as well as participants with advanced and/or metastatic HRP (phase 1 only) ovarian cancer 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. HRP (phase 1 only) or HRRm/HRD+ recurrent 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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165 participants in 3 patient groups

Dose Escalation

Experimental group

Description:

Dose escalation: Multiple dose levels of VIO-01 will be administered via intravenous infusion over a 60-minute period once weekly.

Treatment:

Drug: VIO-01

Dose Expansion HRRm or HRD+ Solid Tumors

Experimental group

Description:

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.

Treatment:

Drug: VIO-01

Dose Expansion HRRm or HRD+ Ovarian Cancer

Experimental group

Description:

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.

Treatment:

Drug: VIO-01