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Dose Escalation for Breast Cancer

Phase 1 & 2

Recruiting

Led By Alexander Philipovskiy, M.D., PhD

Research Sponsored by Valerio Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

Study Summary

This trial is investigating the safety of a new drug called VIO-01 for people with different types of solid tumor cancers. It has two parts: Part 1 looks at how safe and tolerable

Who is the study for?

This trial is for people with recurrent solid tumors, including specific types like prostate, ovarian, and breast cancers. Participants should have previously tried standard treatments without success. The study will also focus on individuals with advanced HRRm or HRD+ solid tumors and those with the same conditions in recurrent ovarian cancer.Check my eligibility

What is being tested?

The trial is testing VIO-01's safety when used alone or alongside other anti-cancer therapies. It consists of two parts: determining the maximum safe dose and how well patients tolerate it (Part 1), followed by assessing its effectiveness in advanced HRRm/HRD+ solid tumors (Part 2).See study design

What are the potential side effects?

While not specified here, typical side effects from new cancer drugs can include nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Dose Limiting Toxicities

Phase 2: Objective Response Rate (ORR)

Secondary outcome measures

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

Phase 2: Duration of response (DOR)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion HRRm or HRD+ Solid TumorsExperimental Treatment1 Intervention

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.

Group II: Dose Expansion HRRm or HRD+ Ovarian CancerExperimental Treatment1 Intervention

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.

Group III: Dose EscalationExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Valerio TherapeuticsLead Sponsor

28 Previous Clinical Trials

3,913 Total Patients Enrolled

1 Trials studying Breast Cancer

115 Patients Enrolled for Breast Cancer

Alexander Philipovskiy, M.D., PhDPrincipal InvestigatorFlorida Cancer Specialists & Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall count of individuals actively participating in this medical study?

"Affirmative. The clinical trial information on clinicaltrials.gov highlights that the study is actively seeking participants. Initially shared on 1/10/2024 and most recently revised on 2/5/2024, this investigation aims to enroll 165 patients at a single location."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the details on clinicaltrials.gov show that this study is currently seeking eligible participants. The trial was first listed on January 10th, 2024 and had its latest update on February 5th, 2024. Enrollment of approximately 165 individuals will take place at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06257758.

All > Prostate Cancer Austin > Recurrent Ovarian Cancer