NCT06911008

MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers

Phase I 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial tests the safety, side effects, and best dose of MTI-301 in treating patients with solid cancers that have spread from where they first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and that have not responded to previous treatment (refractory). MTI-301 is a drug that inhibits an enzyme called SCD1. SCD1 is an enzyme that promotes tumor growth and spread and is upregulated in some cancer types. MTI-301 may disrupt the activity of SCD1, which may lead to reduced tumor growth and/or spread.

Detailed description

PRIMARY OBJECTIVE: I. To assess and determine the maximum tolerated dose (MTD) for SCD1 inhibitor MTI-301 (MTI-301). SECONDARY OBJECTIVES: I. To determine the toxicity profile with MTI-301. II. To determine objective response rate (ORR), progression free survival (PFS) and duration of response (DOR). CORRELATIVE RESEARCH: I. To characterize the pharmacokinetic (PK) profile of MTI-301. II. To assess the levels of SCD1 substrates steric acid, palmitic acid and products oleic acid, palmitoleic acid at baseline, at progression, and at the end of study. III. To assess immune regulator factors from blood at baseline, at progression, and at the end of study. OUTLINE: This is a dose-escalation study of MTI-301. Patients receive MTI-301 orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) and collection of blood samples throughout the study, and undergo tissue sample collection at baseline and at disease progression. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Conditions

• Metastatic Malignant Solid Neoplasm
• Refractory Malignant Solid Neoplasm
• Unresectable Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo tissue and blood sample collection
PROCEDURE	Computed Tomography	Undergo CT or PET/CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Questionnaire Administration	Ancillary studies
BIOLOGICAL	SCD1 Inhibitor MTI-301	Given PO

Timeline

• Start date: 2025-11-07
• Primary completion: 2027-04-09
• Completion: 2027-04-09
• First posted: 2025-04-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study