MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma

Conditions

• Melanoma Stage III
• Melanoma Stage IV
• Metastatic Melanoma
• Recurrent Melanoma (Skin)

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• [203Pb]VMT01 — DRUG
  \[203Pb\]VMT01 is administered intravenous (IV) as an imaging agent for SPECT/CT
• [212Pb]VMT01 — DRUG
  Subjects with positive uptake of \[203Pb\]VMT01 will receive a fixed dose of \[212Pb\]VMT01 administered IV every 8 weeks starting at Cycle 1 Day 1.
• Nivolumab — DRUG
  For all combination-therapy cohorts, 480 mg nivolumab will be administered every 4 weeks as an IV infusion.

Study Details

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.

Key Dates

Start date

Jun 1, 2023

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Monotherapy-Dose Finding
  Enrolled subjects will be treated with \[212Pb\]VMT01 to determine optimal biological dose (OBD). A dosimetry sub-set utilizing \[203Pb\]VMT01 has been incorporated.
• Experimental: Combination Therapy-Dose Finding
  Enrolled subjects will be treated with \[212Pb\]VMT01 in combination with nivolumab to determine OBD. A dosimetry sub-set utilizing \[203Pb\]VMT01 has been incorporated.
• Experimental: Monotherapy - Dose Expansion
  Subjects will be enrolled at previously identified recommended phase 2 dose (RP2D) for confirmation of the RP2D and regimen for the Phase 2 dose-expansion cohort. A dosimetry sub-set utilizing \[203Pb\]VMT01 has been incorporated.
• Experimental: Combination Therapy - Dose Expansion
  Subjects will be enrolled at previously identified RP2D for its confirmation and verification of regimen for the Phase 2 dose-expansion cohort. A dosimetry sub-set utilizing \[203Pb\]VMT01 has been incorporated.

Primary Outcome Measure

Number of subjects with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab. [ Time Frame: Incidence of DLTs during the first 42 days of study Treatment will be assessed. ]

Central Contacts

• ClinicalTrials at Perspectivetherapeutics
  206-676-0900
  [email protected]

Locations (13)

Find similar trials in Orange, CA

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