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[212Pb]VMT01 Monotherapy and Combination With Nivolumab in Melanoma
NCT05655312Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2023
- Primary completion
- Dec 2027
- Countries
- 1
- Modality
- Radiopharmaceutical
- Drugs
- VMT-01
- Conditions
- melanoma
01
Overview
Phase 2, open-label trial of VMT-01 in melanoma (4 arms), sponsored by Perspective Therapeutics, Inc. Primary endpoints: Dose-Limiting Toxicities at 42 days, Objective Response Rate at 2 years and 1 more. Started Jun 2023; status: recruiting.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Monotherapy-Dose Finding
Dose finding for [212Pb]VMT01 monotherapy.
Combination Therapy-Dose Finding
Dose finding for [212Pb]VMT01 in combination with nivolumab.
Monotherapy - Dose Expansion
Dose expansion at RP2D for [212Pb]VMT01 monotherapy.
Combination Therapy - Dose Expansion
Dose expansion at RP2D for [212Pb]VMT01 in combination with nivolumab.
03
Who it enrols
Adults with previously treated unresectable Stage III or IV melanoma with positive MC1R imaging scan.
04
Endpoints
Primary
Dose-Limiting Toxicities
Objective Response Rate
Adverse Events and Serious Adverse Events
Secondary
Duration of Response
Progression-Free Survival
Area Under the Concentration versus Time Curve
Apparent Terminal Elimination Half-Life
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