MTI-201 / Modulation Therap - LARVOL DELTA

Final results of a first-in-human study of the MC1R-targeting radiopharmaceutical 225actinium MTI-201 (225Ac-MTI-201) in metastatic uveal melanoma (mUM). (ASCO 2026) - P1 | "Single dose administration of 225Ac-MTI-201 with dose escalation to 76 µCi appears safe and feasible in mUM. Disease stability in this difficult to treat population is encouraging and a multi-dose study of 225Ac-MTI-201 in mUM is planned pending final pt DLT assessment. 225Ac-MTI-201 has Orphan Drug designation for mUM."

Clinical • First-in-human • Metastases • P1 data • Eye Cancer • Leukopenia • Melanoma • Neutropenia • Solid Tumor • Thrombocytopenia • Uveal Melanoma

MTI201-IA: Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Modulation Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2026 ➔ Mar 2027

Enrollment closed • First-in-human • Trial primary completion date • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

MTI201-IA: Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Modulation Therapeutics, Inc. | Trial primary completion date: Apr 2025 ➔ Mar 2026

Trial primary completion date • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Preliminary results of first-in-human study of 225-Actinium MTI-201 (225Ac-MTI-201) in metastatic uveal melanoma (ESMO 2024) - P1 | "In early assessment, 225Ac-MTI-201 single dose administration appears safe up to 76μCi with PK parameters as anticipated. The observation of disease stability is encouraging. Accrual & dose-escalation is ongoing & a multi-dose study of 225Ac-MTI-201 in mUM is planned."

Metastases • P1 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

First-in-human study of 225 actinium mti-201 ( 225 Ac-MTI-201) in metastatic uveal melanoma (UM). (ASCO 2024) - P1 | "Tebentafusp is the only approved systemic agent for HLA-A*02:01 positive metastatic UM, and novel therapies are needed. 1. Tafreshi, J Nucl Med 2019."

Metastases • P1 data • Eye Cancer • Febrile Neutropenia • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Uveal Melanoma • HLA-A

Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Modulation Therapeutics, Inc. | Trial primary completion date: Dec 2023 ➔ Apr 2025

Metastases • Trial primary completion date • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Modulation Therapeutics, Inc.

New P1 trial • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

WVU gets FDA approval for clinical trial of drug to treat eye cancer ‘from the inside out’ (The Cancer Letter) - "Mark McLaughlin—a researcher with the West Virginia University Cancer Institute and Modulation Therapeutics Inc.—and his colleagues have received FDA approval to begin human trials of a new drug called MTI-201, which treats uveal melanoma after the cancer has traveled to another part of the body. "

IND • Melanoma • Oncology • Uveal Melanoma