Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [203Pb]VMT01
VMT01 · 2 trials · 7 indications
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of \[212Pb\]VMT01 as a monotherapy or in combination with nivolumab
Any untoward medical occurrence in a clinical investigational participant administered \[212Pb\]VMT01 as a monotherapy or in combination with nivolumab. Associated AE or SAE is assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Adverse Events (AEs) will be assessed for severity according to CTCAE v5.0 and for relatedness to each of the investigative imaging agents (\[203Pb\]VMT01 and \[68Ga\]VMT02). Assessments attributed as possibly, probably, or definitely related to the imaging agent will be considered related.
Biodistribution will be calculated by utilizing PET/CT scans.
Biodistribution will be calculated by utilizing SPECT/CT scans.
Cmax will be determined by blood sampling and direct radioactivity measurements.
AUC will be determined by blood sampling and direct radioactivity measurements.
Renal excretion will be determined by urine sampling and direct radioactivity measurements.
Dosimetry will be modeled by utilizing the SPECT/CT scans.
| Arm | Type | Description |
|---|---|---|
| Monotherapy-Dose Finding | EXPERIMENTAL | Enrolled subjects will be treated with \[212Pb\]VMT01 to determine optimal biological dose (OBD). A dosimetry sub-set utilizing \[203Pb\]VMT01 has been incorporated. |
| Combination Therapy-Dose Finding | EXPERIMENTAL | 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. |
| Monotherapy - Dose Expansion | EXPERIMENTAL | 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. |
| Combination Therapy - Dose Expansion | EXPERIMENTAL | 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. |
| [203Pb]VMT01 first | ACTIVE_COMPARATOR | Participants randomized to this arm will receive imaging agent \[203Pb\]VMT01 and undergo SPECT/CT imaging first. Later, participants in this arm will receive \[68Ga\]VMT02 and undergo PET/CT imaging. |
| [68Ga]VMT02 first | ACTIVE_COMPARATOR | Participants randomized to this arm will receive imaging agent \[68Ga\]VMT02 and undergo PET/CT imaging first. Later, participants in this arm will receive \[203Pb\]VMT01 and undergo SPECT/CT imaging. |
| Name | Type | Description |
|---|---|---|
| [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. |
| [68Ga]VMT02 | DRUG | Diagnostic imaging radiopharmaceutical; by intravenous infusion |
Inclusion Criteria: * Ability to understand and willingness to provide informed consent, willingness to comply with all study procedures for the duration of the study * Aged ≥ 18 years * Diagnosed with unresectable Stage III or Stage IV metastatic or recurrent melanoma * Previously progressed (radi...
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VMT01 is an investigational small molecule being studied for the treatment of melanoma, including recurrent melanoma of the skin. It is being evaluated in patients with advanced melanoma, including stage III and stage IV disease, as well as metastatic melanoma.
VMT01 targets MC1R, the melanocortin 1 receptor. This receptor is expressed on melanoma cells, and VMT01 is designed to deliver alpha-particle radiation specifically to MC1R-positive tumors.
VMT01 is being developed by Perspective Therapeutics, Inc., a company traded on the stock exchange under the ticker CATX.
VMT01 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted it Fast Track designation for the treatment of melanoma.
VMT01 is being studied in two Phase 1 clinical trials. NCT04904120 is a completed trial of targeted imaging for alpha-particle radiotherapy in melanoma. NCT05655312 is an actively recruiting trial of VMT01 as monotherapy and in combination with nivolumab in adults with advanced melanoma.
Yes, VMT01 is also known as [203Pb]VMT01. The [203Pb] designation refers to the lead-203 isotope used in the imaging version of the compound, which allows for visualization of MC1R-positive tumors.