RVP-001 for Brain Tumors

Recruiting at 3 trial locations

Overseen By Skye Sully

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Reveal Pharmaceuticals Inc.

Must not be taking: Linear GBCA

Disqualifiers: Cardiac disease, MRI incompatibility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

24 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What is the purpose of this trial?

This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis. The goal of this study is to assess safety, efficacy, and pharmacokinetics of RVP-001 at three dose levels. The study will also compare RVP-001 imaging to gadolinium-based contrast agent (GBCA) imaging. A single dose of RVP-001 will be administered to each subject. Subjects will have known gadolinium-enhancing CNS lesions and will have a gadolinium-based contrast agent-enhanced MRI of the brain 2-14 days before receiving RVP-001 with imaging. The ultimate goal of this research program is development of a gadolinium-free alternative to current general purpose MRI contrast agents.

Research Team

Vera Hoffman

Principal Investigator

Reveal Pharmaceuticals

Srini Mukundan, M.D./PhD.

Principal Investigator

Reveal Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

I've had an MRI showing a brain lesion larger than 5mm.

My kidney function is within normal ranges.

I am under MRI surveillance for my brain lesions and can have an MRI every six weeks after taking RVP-001.

Exclusion Criteria

MRI incompatibility

I do not have a serious illness that could interfere with the study.

I have received a specific contrast agent for an MRI scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Imaging

Baseline unenhanced MRI scan performed prior to RVP-001 injection

1 day

1 visit (in-person)

Treatment

Single dose of RVP-001 administered with dynamic and steady state imaging

1 day

1 visit (in-person)

Follow-up

Unenhanced MRI scan follow-up study performed between one week and six weeks following RVP-001 administration

1-6 weeks

1 visit (in-person)

Treatment Details

Interventions

• RVP-001

Trial Overview 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.

Participant Groups

Group I: 7 mg/Mn/kg Experimental Treatment 1 Intervention

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

Group II: 2 mg/Mn/kg Experimental Treatment 1 Intervention

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

Group III: 12 mg/Mn/kg Experimental Treatment 1 Intervention

6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg

Who Is Running the Clinical Trial?

Reveal Pharmaceuticals Inc.

Lead Sponsor

Trials

2

Recruited

60+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+