← Back to Search

Radiopharmaceutical

Targeted Alpha-Particle Therapy for Melanoma

Phase 1 & 2

Recruiting

Research Sponsored by Perspective Therapeutics

Eligibility Criteria Checklist

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

Must have

Diagnosed with Stage IV metastatic melanoma, or unresectable Stage III

Previously progressed (clinical or radiological progression) on at least one prior therapy for metastatic melanoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing if a new drug can safely and effectively treat unresectable and metastatic melanoma.

Who is the study for?

Adults over 18 with advanced melanoma that's spread or can't be removed by surgery, who've had at least one prior treatment fail. They must have a tumor visible on specific scans, be able to lie still for imaging, and not be pregnant or breastfeeding. Men and women must agree to use effective contraception.Check my eligibility

What is being tested?

[212Pb]VMT01 is being tested for safety and effectiveness in treating advanced melanoma. It's an alpha-particle therapy targeting MC1R receptors on cancer cells. This trial will include patients whose tumors absorb a related compound seen in special imaging tests.See study design

What are the potential side effects?

Potential side effects may include reactions from the radioactive material such as nausea, fatigue, local skin reactions where the drug is injected, and possible changes in blood counts due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My melanoma is at an advanced stage and cannot be surgically removed.

Select...

My melanoma has worsened after at least one treatment.

Select...

My melanoma shows up on special scans compared to normal tissue.

Select...

I can stay still for 2 hours during scans, with mild sedation if needed.

Select...

I can do most of my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with dose-limiting toxicities (DLTs) through 42 days following last dose of [212Pb]VMT01-T101

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of patients with laboratory abnormalities [Time Frame: Through 42 days following last dose of [212Pb]VMT01; up to 3 years]

+1 more

Secondary outcome measures

Apparent terminal elimination half-life (T1/2) [Time Frame: Through 42 days following last dose of [212Pb]VMT01; up to 6 months]

Area under the concentration-time curve (AUC) [Time Frame: Through 42 days following last dose of [212Pb]VMT01; up to 3 years]

Duration of response (DOR) following treatment with [212Pb]VMT01

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion with RPh2DExperimental Treatment1 Intervention

Up to 20 patients with advanced or metastatic melanoma

Group II: Dose EscalationExperimental Treatment2 Interventions

Dose Escalation to determine MTD/MFD among 4 different dose levels in up to 32 patients receiving up to 3 administrations of [212Pb]VMT01 approximately 8 weeks apart. The second part of the study is a dose expansion based on the identified MTD/MFD for the selection of [212Pb]VMT01 dose(s) in up to 20 additional subjects for further clinical development. A dosimetry sub-study utilizing [203Pb]VMT01 has been incorporated into the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[203Pb]VMT01

2021

Completed Phase 1

~10

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Perspective TherapeuticsLead Sponsor

4 Previous Clinical Trials

103 Total Patients Enrolled

1 Trials studying Melanoma

7 Patients Enrolled for Melanoma

Viewpoint Molecular TargetingLead Sponsor

3 Previous Clinical Trials

79 Total Patients Enrolled

1 Trials studying Melanoma

7 Patients Enrolled for Melanoma

Media Library

[212Pb]VMT01 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05655312 — Phase 1 & 2

Melanoma Research Study Groups: Dose Expansion with RPh2D, Dose Escalation

Melanoma Clinical Trial 2023: [212Pb]VMT01 Highlights & Side Effects. Trial Name: NCT05655312 — Phase 1 & 2

[212Pb]VMT01 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05655312 — Phase 1 & 2

Frequently Asked Questions

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

Is the patient pool for this research experiment limited to those above a certain age?

"This research project is currently seeking participants aged over 18 years and below the age of 90."

Answered by AI

What type of patient does this trial primarily seek to recruit?

"The eligibility criteria of this trial necessitates that the patient is between 18 and 90 years old, with a confirmed diagnosis of melanoma. A total of 52 people will be taken into consideration for inclusion in the study."

Answered by AI

Does this research initiative currently have any open enrollment slots?

"Clinicaltrials.gov reveals that the recruitment for this trial has already closed, with its initial posting on December 15th 2022 being followed by a last update on December 8th 2022. Despite no longer accepting participants, 781 other studies are presently recruiting patients at this time."

Answered by AI

What is the purpose of this experiment?

"This trial surveys patients for up to 3 years, with the primary outcome being any treatment-related adverse events as recorded in CTCAE v4.0. Secondary endpoints have been assigned to measure pharmacokinetic parameters (area under the concentration-time curve and apparent terminal elimination half life) and progression free survival when subject receive at least one dose of [212Pb]VMT01, which is assessed by RECIST v1.1 criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma

2023. "MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05655312.