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Virus Therapy

RVP-001 for Brain Tumors

Phase 2
Recruiting
Led By Vera Hoffman
Research Sponsored by Reveal Pharmaceuticals Inc.
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 from time of dosing to 7 days post dose
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety, effectiveness, and how the drug moves through the body of a new medication called RVP 001. It will be given to patients with specific brain lesions through an IV

Who is the study for?
This trial is for adults aged 18-65 with brain tumors, who've had a recent MRI showing at least one lesion of minimum 5mm. They must have good kidney function and be able to follow up with MRIs. It's not for those with serious non-cancer diseases, certain heart conditions, or who've used specific contrast agents in their MRI.
What is being tested?
The study tests RVP-001 given as a single IV shot at three increasing doses. It aims to see how safe it is and how well it works in people with brain lesions that show up on MRIs using gadolinium-based contrast.
What are the potential side effects?
While the side effects of RVP-001 are not detailed here, similar drugs may cause reactions at the injection site, allergic responses, changes in blood chemistry or pressure, headaches or dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of dosing to 7 days post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of dosing to 7 days post dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA)
Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05413668
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
RVP-001: 2 mg Mn/kg
RVP-001: 7 mg Mn/kg
Placebo Group
RVP-001: 12 mg Mn/kg
RVP-001: 4 mg Mn/kg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: 7 mg/Mn/kgExperimental Treatment1 Intervention
6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg
Group II: 2 mg/Mn/kgExperimental Treatment1 Intervention
6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg
Group III: 12 mg/Mn/kgExperimental Treatment1 Intervention
6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RVP-001
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,036 Total Patients Enrolled
3 Trials studying Neurofibromatosis
290 Patients Enrolled for Neurofibromatosis
Reveal Pharmaceuticals Inc.Lead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Srini Mukundan, M.D./PhD.Study DirectorReveal Pharmaceuticals
~5 spots leftby Feb 2025
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