Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06911008

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

Led by Mayo Clinic · Updated on 2026-03-19

42

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed metastatic or unresectable solid tumor cancer that is refractory or intolerant to standard therapies
  • Measurable or evaluable disease by RECIST criteria
  • ECOG performance status of 0, 1, or 2
  • Hemoglobin level of 9.0 g/dL or higher within 28 days before registration
  • Absolute neutrophil count of 1500/mm8 or higher within 28 days before registration
  • Platelet count of 100,000/mm8 or higher within 28 days before registration
  • Total bilirubin level less than or equal to 1.5 times the upper limit of normal (ULN), or up to 3 times ULN for patients with Gilbert's syndrome within 28 days before registration
  • ALT and AST levels less than or equal to 3 times ULN, or up to 5 times ULN for patients with liver involvement within 28 days before registration
  • Prothrombin time (PT)/INR/aPTT less than or equal to 1.5 times ULN or within target range if on anticoagulant therapy within 28 days before registration
  • Calculated creatinine clearance of 60 mL/min or higher using Cockcroft-Gault formula within 28 days before registration
  • Negative pregnancy test within 7 days before registration for persons of childbearing potential
  • Ability to provide written informed consent
  • Ability to complete questionnaires independently or with assistance
  • Willingness to provide mandatory blood and tissue samples for research
  • Willingness to return for follow-up visits during active monitoring phase
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons
  • Persons of childbearing potential unwilling to use highly effective contraception methods
  • Major surgery within 3 weeks prior to registration
  • Chemotherapy within 2 weeks prior to registration
  • Immunotherapy within 3 weeks prior to registration
  • Radiation therapy within 2 weeks prior to registration
  • Severe systemic illnesses or concurrent diseases that interfere with safety assessment
  • Immunocompromised patients, including those with HIV on antiretroviral therapy or active hepatitis B or C treatment
  • Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, significant cardiac arrhythmia, bleeding disorders, psychiatric illnesses limiting compliance, or continuous oxygen therapy due to dyspnea
  • History of myocardial infarction within 6 months or life-threatening ventricular arrhythmias requiring ongoing therapy
  • Other active malignancy within 3 years except non-melanotic skin cancer or carcinoma in situ of the cervix
  • Unresolved toxicity from prior chemotherapy above grade 1
  • Use of other investigational agents or devices within 14 days prior to registration
  • Planned other cancer treatments during the study
  • Untreated fluid retention or history of severe capillary leak syndrome
  • Active or symptomatic brain metastases, active CNS tumors, or carcinomatosis meningitis
  • Grade 2 or higher neuropathy excluding carpal tunnel syndrome
  • Use of medications that inhibit or are substrates of major CYP enzymes or transporters within 14 days prior to registration
  • Corrected QT interval prolongation (QTcF 20 ms or greater)
  • Corneal conditions such as confluent superficial keratitis, corneal ulcer, or stromal opacity
  • Significant electrolyte imbalance
  • Uncontrolled congestive heart failure or symptomatic cardiac arrhythmia
  • Genetic predisposition to long QT syndrome
  • Use of concomitant QT prolonging medications
  • Any other condition that would limit study compliance or safety as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

Loading map...

Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here