AzTrials
AzTrials

Advanced or Metastatic Solid TumorsPhase 1/2NCT06257758

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

A Phase 1/2 study testing VIO-01 in people with Advanced or Metastatic Solid Tumors and Breast Cancer, run by Valerio Therapeutics at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VIO-01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesUnited States
Study dates
10 Jan 2024to 1 Jan 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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.
  • 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:
  • 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.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Florida Cancer Specialists & Research Institute

    Lake Mary, Florida, 32746

  • Stephenson Cancer Center - University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Next Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

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:

Read more
  • 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.

Read the 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 (i.e. BRCA1/2 mutated breast cancer, HRR mutated prostate cancer) or HRRm/HRD+/HRP (phase 1 only) recurrent ovarian cancer.

Being tested
VIO-01
Keywords
Solid tumors, Breast cancer, Ovarian cancer, Prostate cancer
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIO-01Drug

    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.

Study groups in NCT06257758
Study groupRoleWhat they receive
Dose EscalationExperimentalDose escalation: Multiple dose levels of VIO-01 will be administered via intravenous infusion over a 60-minute period once weekly.
Receives: Drug: VIO-01
Dose Expansion HRRm or HRD+ Solid TumorsExperimentalParticipants 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.
Receives: Drug: VIO-01
Dose Expansion HRRm or HRD+ Ovarian CancerExperimentalParticipants 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.
Receives: Drug: VIO-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Dose Limiting Toxicities

    As measured by adverse events observed

    Measured: Baseline to 12 months

  2. 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.

    Measured: Baseline to 12 months

Secondary outcomes (4)

  1. 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.

    Measured: Baseline to 12 months

  2. 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)

    Measured: Baseline to 12 months

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

    Safety PK parameters: total exposure including Peak Plasma Concentration (Cmax).

    Measured: Baseline to 12 months

  4. 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.

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start10 Jan 2024
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257758
Sponsor's protocol ID
VIO-01-101
Status last verified
Jun 2024
First submitted
22 Jan 2024
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VIO-01 in people with Advanced or Metastatic Solid Tumors and Breast Cancer, run by Valerio Therapeutics at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Dose Limiting Toxicities (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06257758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in