Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT05655312
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2022-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Sponsor:
Perspective Therapeutics
Organization:
Study Overview
Official Title:
A Phase I/IIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Finding and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.
Detailed Description:
This is a prospective, multi-center open-label dose-finding, dose-expansion study of \[212Pb\]VMT01 as a monotherapy or in combination with nivolumab in up to 300 subjects with histologically confirmed melanoma and a positive MC1R imaging scan with imaging agents \[203Pb\]VMT01 or \[68Ga\]VMT02.
MC1R is a receptor that is expressed on the surface of melanoma cells and therefore is an attractive therapeutic target for melanoma treatment. Lead-212 (\[212Pb\]-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.
This study will be conducted in 3 parts:
Part 1: Monotherapy Dose-Finding
Part 2: Combination-Therapy Dose-Finding
Part 3: Dose Expansion
Enrolled subjects in Monotherapy may receive up to 3 doses of \[212Pb\]VMT01 approximately 8 weeks apart and subjects in combination therapy may receive up to 3 doses of \[212Pb\]VMT01 along with nivolumab. Nivolumab will be administered every 4 weeks for up to 24 months.
A Dosimetry sub-set utilizing an imaging surrogate, \[203Pb\]VMT01, has been incorporated into the study in order to assess organ biodistribution and tumor uptake of the investigational products. This study will also estimate radiation dosimetry and correlate uptake of the investigation products with observed toxicities and efficacy.
MC1R is a receptor that is expressed on the surface of melanoma cells and therefore is an attractive therapeutic target for melanoma treatment. Lead-212 (\[212Pb\]-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.
This study will be conducted in 3 parts:
Part 1: Monotherapy Dose-Finding
Part 2: Combination-Therapy Dose-Finding
Part 3: Dose Expansion
Enrolled subjects in Monotherapy may receive up to 3 doses of \[212Pb\]VMT01 approximately 8 weeks apart and subjects in combination therapy may receive up to 3 doses of \[212Pb\]VMT01 along with nivolumab. Nivolumab will be administered every 4 weeks for up to 24 months.
A Dosimetry sub-set utilizing an imaging surrogate, \[203Pb\]VMT01, has been incorporated into the study in order to assess organ biodistribution and tumor uptake of the investigational products. This study will also estimate radiation dosimetry and correlate uptake of the investigation products with observed toxicities and efficacy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: