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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257758
• Other study ID #: VIO-01-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 10, 2024
• Est. completion date: December 28, 2028

Study information

• Verified date: June 2024
• Source: Valerio Therapeutics
• Contact: Lisa Fitzgerald
• Phone: 1-617-485-1458
• Email: l.fitzgerald[@]valeriotx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 28, 2028
• Est. primary completion date: January 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Breast Cancer
• Ovarian Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence
• Recurrent Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Valerio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Dose Limiting Toxicities	As measured by adverse events observed	Baseline to 12 months
Primary	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	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.	Baseline to 12 months
Secondary	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)	Baseline to 12 months
Secondary	Phase 1: Assess the pharmacokinetics (PK) of VIO-01	Safety PK parameters: total exposure including Peak Plasma Concentration (Cmax).	Baseline to 12 months
Secondary	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.	Baseline to 12 months