Phase 1 Trial / MTI-301

December 2025

Modulation Therapeutics is pleased to announce the activation of a Phase 1 Clinical Trial to evaluate the safety, tolerability, pharmacokinetics and activity of MTI-301 in patients with advanced solid tumor malignancy.

MTI-301 is an orally administered novel small molecule drug that inhibits an enzyme called stearoyl CoA desaturase 1 (SCD1). SCD1 promotes monounsaturated fatty acid (MUFAs) synthesis in cancer cells.  Tumor growth, metastasis, and drug resistance in multiple cancer types have been associated with MUFAs. In pre-clinical studies, MTI-301 has been shown to inhibit the activity of SCD1 and reduced tumor growth and/or spread.

The MTI-301 Phase 1 clinical trial entitled “Phase 1 trial of SCD I: A First in Human Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Activity of MTI-301 in Patients with Advanced Malignancy" is supported in part by a NIH Grant (R44CA272064).

More information on the Phase 1 clinical trial with MTI-301 can be found at: "www.clinicaltrials.gov" (Trial Identifier: NCT06911008); “www.cancer.gov” (Trial Identifier; NCI-2025-01930; “www.mayo.edu/research/clinical-trials” (Trial Identifier MC210103).