MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers
NCT06911008 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-03-19
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.
Conditions
- Metastatic Malignant Solid Neoplasm
- Refractory Malignant Solid Neoplasm
- Unresectable Malignant Solid Neoplasm
Interventions
- 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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Winston Tan, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-07
- Primary Completion
- 2027-04-09
- Completion
- 2027-04-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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