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

NCT06257758 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: VIO-01-101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Solid tumors; Breast cancer; Ovarian cancer; Prostate cancer

Outcome Measures

Primary Outcomes (2)

• Phase 1: Dose Limiting Toxicities

  As measured by adverse events observed

  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.

  Baseline to 12 months

Secondary Outcomes (4)

• Phase 1: Assess the pharmacokinetics (PK) of VIO-01

  Baseline to 12 months

• Phase 1: Assess the pharmacokinetics (PK) of VIO-01

  Baseline to 12 months

• Phase 1: Assess the pharmacokinetics (PK) of VIO-01

  Baseline to 12 months

• Phase 2: Duration of response (DOR)

  Baseline to 12 months

Study Arms (3)

Dose Escalation

EXPERIMENTAL

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

Drug: VIO-01

Dose Expansion HRRm or HRD+ Solid Tumors

EXPERIMENTAL

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

Dose Expansion HRRm or HRD+ Ovarian Cancer

EXPERIMENTAL

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

Interventions

VIO-01 DRUG

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.

Dose Escalation; Dose Expansion HRRm or HRD+ Ovarian Cancer; Dose Expansion HRRm or HRD+ Solid Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have measurable disease per RECIST 1.1
• 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:
• BRCA1/2 mutated breast cancer.
• HRP (phase 1 only) or HRRm/HRD+ recurrent ovarian cancer.
• HRR mutated prostate cancer.
• Select HRRm or HRD+ solid tumors with Medical Monitor approval.
• For Participants with metastatic breast cancer:
• Histologically or cytologically confirmed recurrent or relapsed breast cancer.
• Advanced stage metastatic disease as documented by imaging.
• 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.
• 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.
• Participants with ER+ tumors should have progressed on prior CDK4/6 inhibitors (in addition to hormonal therapy) to be eligible.
• Participants with triple negative breast cancer (TNBC) should have received sacituzumab prior to study enrollment.
• Willingness to provide pre-treatment and on-treatment biopsies.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Valerio Therapeutics: lead

Study Sites (3)

Florida Cancer Specialists & Research Institute

Lake Mary, Florida, 32746, United States

Location

Stephenson Cancer Center - University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Next Oncology

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alexander Philipovskiy, M.D., PhD

  Florida Cancer Specialists & Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be a modular design conducted in two phases. Each module will consist of a dose escalation and dose expansion portion. The study will initially begin with Module A evaluating VIO-01 as a monotherapy. Based on emerging PK and PD data, a protocol amendment implementing additional modules evaluating combination therapies with VIO-01 may be added. After the completion the Module A dose escalation, additional enrollment into expansion cohorts or other modules may proceed in parallel.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 14, 2024
• Study Start: January 10, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)