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Virus Therapy

7 mg/Mn/kg for Brain Tumor

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of dosing to 7 days post dose

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

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

Primary outcome measures

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%

Study treatment Arm

RVP-001: 2 mg Mn/kg

RVP-001: 7 mg Mn/kg

RVP-001: 4 mg Mn/kg

Placebo Group

RVP-001: 12 mg Mn/kg

Trial Design

3Treatment groups

Experimental Treatment

Group I: 7 mg/Mn/kgExperimental Treatment1 Intervention

6 subjects each will receive RVP-001 at a doses of 7 mg Mn/kg

Group II: 2 mg/Mn/kgExperimental Treatment1 Intervention

6 subjects each will receive RVP-001 at a doses of 2 mg Mn/kg

Group III: 12 mg/Mn/kgExperimental Treatment1 Intervention

6 subjects each will receive RVP-001 at a doses 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,669 Previous Clinical Trials

40,926,377 Total Patients Enrolled

Reveal Pharmaceuticals Inc.Lead Sponsor

1 Previous Clinical Trials

32 Total Patients Enrolled

Srini Mukundan, M.D./PhD.Study DirectorReveal Pharmaceuticals

Frequently Asked Questions

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

Are new participants currently being welcomed to enroll in this trial?

"Indeed, the details on clinicaltrials.gov indicate that this trial is presently seeking participants. Its posting date was 4/1/2024, with the most recent update recorded as 3/18/2024. The study aims to enroll a total of 24 individuals distributed among 3 locations."

Answered by AI

Are individuals older than 45 years eligible to participate in this study?

"This clinical investigation is open to individuals aged 18 and older but under the age of 65."

Answered by AI

Has the FDA granted approval for a dosage of 7 milligrams per square meter per kilogram?

"The safety evaluation of 7 mg/Mn/kg is rated at 2 by our team due to the ongoing Phase 2 trial, indicating some existing safety data but lacking evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent

2024. "Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06322342.

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