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Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma

This study will enroll patients with metastatic uveal melanoma that have failed at least one form of therapy from a single academic medical center in the United States. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures. A continual reassessment method (CRM) design will be used for this clinical trial. The study proposes single patient cohorts with dose escalation starting at 4.7 microCi of 225Ac-MTI-201 after each cohort in the absence of safety concerns (2- fold increases for doses and lower dose increases between higher doses). Dose Limiting Toxicities will be assessed using the CTCAE version 5.0 criteria.

The participants who meet the eligibility requirements will be administered a single intravenous dose of 225Ac-MTI-201. After study treatment at the Moffitt Cancer Research Center in Tampa, Florida, the study participants will stay overnight at the study center, undergo study procedures(i.e. vital signs, physical exam, multiple blood and urine sample collections) and will be scheduled to return to the clinic at 48 hours and for additional appointments of weekly clinic visits during the first month and on Week 9 for health status assessments, including physical exams, complete blood chemistry, and EKG. Tumor measurements every 8 weeks in first year post-injection; extended to 12 weeks in year 2; every 16 weeks in year 3, and 24 weeks in years 4 and 5. The clinic visits will involve seeing a study doctor plus radiological tests (such as MRI and/or CT scans) to see how the metastatic uveal melanoma has responded to the study drug.

February 2023

Modulation Therapeutics Announces receipt of a peer reviewed Fast Track SBIR award from the National Institutes of Health and the National Cancer Institute to complete research with MTI-301, a First in Class SCD-1 inhibitor for treating multiple cancers.

The FastTrack SBIR award will be funded in 2 milestone driven phases totaling up to $2.4M supporting both preclinical and first in human phase I clinical studies to assess the safety, tolerability, and pharmacokinetics of MTI-301, a Stearoyl CoA desaturase 1 (SCD1) inhibitor, as a therapeutic strategy for patients with advanced solid tumors in breast, liver, gastrointestinal and genitourinary cancers.

January 2023

Modulation Therapeutics Announces successful metastatic Uveal Melanoma patient enrollment for a Phase 1 Clinical Trial of the First in Class Targeted Alpha Therapeutic (TAT), 225Ac-MTI-201.

The Phase I trial was initiated in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL on July 21, 2022, under the clinical leadership of Dr. Nikhil I. Khushalani, Vice Chair of the Department of Cutaneous Oncology at Moffitt. In this actively accruing dose escalation trial in advanced uveal melanoma, the primary objective is to determine the safety and tolerability of a single dose of intravenously administered 225Ac-MTI-201. The secondary end-points are to determine the pharmacokinetics of 225Ac-MTI-201 and assess efficacy in this deadly disease.

225Ac-MTI-201 is analogous to the FDA-approved Peptide Receptor Radiotherapeutic (PRRT) Lutathera which targets somatostatin subtype 2 receptors for delivery of the beta particle emitting radionuclide, 177Lu, for the treatment of gastroenteropancreatic neuroendocrine tumors. 225Ac-MTI-201 targets the melanocortin 1 receptor which is highly expressed on metastatic uveal melanoma tumors and delivers the alpha-particle emitting radionuclide, 225Ac.

Currently, there is only one FDA approved treatment for metastatic uveal melanoma and only half of uveal melanoma patients are eligible for this treatment. Modulation Therapeutics and collaborators seek to aid all patients experiencing this devastating disease with this First in Class Targeted Alpha Therapy. The FDA has granted Orphan Drug Designation to 225Ac-MTI-201. Modulation Therapeutics is looking forward to successful completion of the phase 1 trial in order to support an early to market phase 2 strategy for this indication.

More information on the phase 1 clinical trial with 225Ac-MTI-201 can be found at: "" (Trial Identifier: NCT05496686).

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