Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05655312
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2022-11-15
Brief Title:
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Sponsor:
Perspective Therapeutics
Organization:
Perspective Therapeutics
Study Overview
Official Title:
A Phase IIIa First-In-Human Multi-Center Monotherapy and Combination-Therapy With Nivolumab Dose-Escalation and Dose-Expansion Study of 212PbVMT01 Melanocortin-1 Receptor-Targeted Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma
Status:
RECRUITING
Status Verified Date:
2024-09
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 IIIa study the safety and efficacy of 212PbVMT01 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-escalation dose-expansion study of 212PbVMT01 as a monotherapy or in combination with Nivolumab in up to 264 subjects with histologically confirmed melanoma and a positive MC1R imaging scan with imaging agents 203PbVMT01 or 68GaVMT02
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-Escalation 212PbVMT01 is administered alone in escalating doses to determine the Maximum Tolerated radioactivity Dose MTD Maximum Feasible radioactivity Dose MFD and potential recommended Phase 2 doses RP2Ds
Part 2 Combination-Therapy Dose-Escalation 212PbVMT01 and Nivolumab are administered in escalating doses to determine MTD MFD and RP2Ds
Part 3 Dose Expansion This part will enroll subjects in monotherapy and combination-therapy expansion cohorts based on the identified MTD MFD and RP2D for the selection of 212PbVMT01 alone and 212PbVMT01-Nivolumab combination doses for further clinical development
Enrolled subjects in Monotherapy part may receive up to 3 doses of 212PbVMT01 approximately 8 weeks apart and subjects in combination therapy may receive nivolumab every 4 weeks for up to 24 months
A Dosimetry sub-study utilizing an imaging surrogate 203PbVMT01 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-Escalation 212PbVMT01 is administered alone in escalating doses to determine the Maximum Tolerated radioactivity Dose MTD Maximum Feasible radioactivity Dose MFD and potential recommended Phase 2 doses RP2Ds
Part 2 Combination-Therapy Dose-Escalation 212PbVMT01 and Nivolumab are administered in escalating doses to determine MTD MFD and RP2Ds
Part 3 Dose Expansion This part will enroll subjects in monotherapy and combination-therapy expansion cohorts based on the identified MTD MFD and RP2D for the selection of 212PbVMT01 alone and 212PbVMT01-Nivolumab combination doses for further clinical development
Enrolled subjects in Monotherapy part may receive up to 3 doses of 212PbVMT01 approximately 8 weeks apart and subjects in combination therapy may receive nivolumab every 4 weeks for up to 24 months
A Dosimetry sub-study utilizing an imaging surrogate 203PbVMT01 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:
None
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?:
None