On October 16, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), reported the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01 (clinicaltrials.gov identifier NCT05655312), its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma (Press release, Perspective Therapeutics, OCT 16, 2023, https://perspectivetherapeutics.com/press-releases/perspective-therapeutics-completes-recruitment-for-first-patient-cohort-in-phase-1-2a-dose-escalation-trial-of-vmt01-in-malignant-melanoma/ [SID1234636018]).
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"We are encouraged by the pace of enrollment in the trial which we believe is indicative of the tremendous unmet need for patients with unresectable and intractable melanomas," said Chief Medical Officer Markus Puhlmann, MD MBA, of Perspective Therapeutics. "We are grateful to our clinical collaborators for their diligence in working closely with patients to deliver our targeted alpha-particle therapy, and we look forward to providing an update in the coming months."
"MC1R is a receptor that is displayed on the surface of melanoma cells, making it an attractive target for the treatment of malignant melanomas," said Zachary S. Morris, M.D., Ph.D., Vice Chair and Endowed Professor of Human Oncology, Program Director for the University of Wisconsin Bentson Research Fellowship, and Principal Investigator for the VMT01 clinical study. "Systemic delivery of an MC1R-targeted alpha-particle emitting therapeutic may have potential to eliminate all associated lesions. Given our interactions to date, we are excited to continue our work with Perspective to address this disease with high unmet medical need."
About the study
This ongoing trial (clinicaltrials.gov identifier NCT05655312) is a multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in subjects with histologically confirmed melanoma and positive MC1R imaging scans. The first part of the study is a dose escalation phase to determine the Maximum Tolerated radioactivity Dose (MTD) or Maximum Feasible radioactivity Dose (MFD) following a single administration of 212Pb-VMT01. Patients with stage IV or unresectable stage III metastatic melanoma who have progressed on at least 1 approved first-line therapy will be scheduled to receive up to 3 administrations of 212Pb-VMT01 approximately 8 weeks apart. The first patient cohort is scheduled to receive 111 MBq (3mCi) per dose. The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi) respectively, if the MTD or MFD is not reached during escalation. According to the Modified Toxicity Probability Interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study.
The second part of the study is a dose expansion phase based on the identified MTD/MFD. Patients may be eligible to receive up to three administrations of 212Pb-VMT01 approximately eight weeks apart. A dosimetry sub-study is included to assess biodistribution, tumor uptake and correlation of uptake with observed toxicities and efficacy.
About Melanoma
Melanoma is a cancer of the skin arising from uncontrollable growth of melanocytes, the melanin producing cells of the body. Metastatic melanoma is the result of melanoma that has progressed through the layers of skin, infiltrated the blood stream or lymphatic system, and traveled to other areas of the body to metastasize. In the United States, there are approximately 100,000 new diagnoses of melanoma annually and approximately 6,850 deaths annually from metastatic melanoma (cancer.org). In most cases, metastatic melanoma cannot be cured but treatment can support a longer life.
About VMT01
VMT01 is a proprietary clinical-stage low molecular weight peptide that is targeted to the melanocortin subtype 1 receptor (MC1R) which is over-expressed on melanoma cells. VMT01 is in development for the treatment and diagnosis of MC1R-positive metastatic melanoma. VMT01 can be labeled with 212Pb to deliver alpha-particle radiation directly to tumor cells, or 203Pb to enable patient selection, diagnostic imaging and dosimetry via SPECT imaging. The product recently completed a pilot imaging study at the Mayo Clinic Rochester, MN. In August 2023, the Company announced that the first patient was dosed in the Phase1/2a study of VMT01 (clinicaltrials.gov identifier NCT05655312).