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

NCT06911008 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: MC210103NCI-2025-0193024-012791R44CA272064
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT will be defined as an adverse event attributed as definitely, probably, or possibly related to MTI-301.

  Up to 28 days (1 cycle)

• Incidence of adverse events

  Will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized. Grade 3+ adverse events will be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination.

  Up to 30 days after last dose of study treatment

Secondary Outcomes (3)

• Objective response rate

  Up to 6 cycles (1 cycle = 28 days)

• Duration of response

  Up to 1 year

• Progression free survival

  Up to 1 year

Study Arms (1)

Treatment (MTI-301)

EXPERIMENTAL

Patients receive MTI-301 PO 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 CT, PET/CT, or MRI and collection of blood samples throughout the study, and undergo tissue sample collection at baseline and at disease progression.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Biological: SCD1 Inhibitor MTI-301

Interventions

Biospecimen Collection PROCEDURE

Undergo tissue and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (MTI-301)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (MTI-301)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (MTI-301)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (MTI-301)

Questionnaire Administration OTHER

Ancillary studies

Treatment (MTI-301)

SCD1 Inhibitor MTI-301 BIOLOGICAL

Given PO

Also known as: MTI-301; MTI301; MTI 301; Stearoyl-CoA Desaturase 1 Inhibitor MTI-301; SSI-4; SSI4; SSI 4; ); 2-{[4-(2-Chlorophenoxy)piperidine-1-carbonyl]amino}-N-methylpyridine-4-carboxamide

Treatment (MTI-301)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically or cytologically confirmed solid tumor (cancer) that is metastatic or unresectable and who are refractory to or intolerant of existing, standard-of-care therapy(ies), known to provide clinical benefit for their condition.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or evaluable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
• Hemoglobin ≥ 9.0 g/dL (obtained ≤ 28 days prior to registration).
• Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 28 days prior to registration).
• Platelet count ≥ 100,000/mm\^3 (obtained ≤ 28 days prior to registration).
• Total bilirubin ≤ 1.5 x upper limit normal (ULN). Patients with Gilbert's syndrome: Total bilirubin ≤ 3 x ULN (obtained ≤ 28 days prior to registration).
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 28 days prior to registration).
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy as determined by treating investigator (obtained ≤ 28 days prior to registration).
• Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 28 days prior to registration).
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
• NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Provide written informed consent.
• Ability to complete questionnaire(s) by themselves or with assistance.

You may not qualify if:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons who are of childbearing potential who are unwilling to employ adequate contraception.
• NOTE: For the purpose of this guidance, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \[Hormonal contraception may be susceptible to interaction with the investigational medicinal product (IMP), which may reduce the efficacy of the contraception method.\]:
• Oral
• Intravaginal
• Transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation (Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the contraception method.):
• Oral
• Injectable
• Implantable (Contraception methods that in the context of this guidance are considered to have low user dependency.)
• Intrauterine device (IUD) (Contraception methods that in the context of this guidance are considered to have low user dependency)
• Intrauterine hormone-releasing system (IUS) (Contraception methods that in the context of this guidance are considered to have low user dependency.)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Winston Tan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)