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Metastatic Malignant Solid NeoplasmPhase 1NCT06911008

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

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
7 Nov 2025to 9 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willingness to provide mandatory tissue specimens for correlative research.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Who cannot join

  • 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.]:
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  • 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.)
  • Bilateral tubal occlusion (Contraception methods that in the context of this guidance are considered to have low user dependency.)
  • Vasectomised partner [Contraception methods that in the context of this guidance are considered to have low user dependency. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the women of childbearing potential (WOCBP) trial participant and that the vasectomised partner has received medical assessment of the surgical success.]
  • Sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.).
  • Any of the following prior therapies:
  • Major surgery ≤ 3 weeks prior to registration
  • Chemotherapy ≤ 2 weeks prior to registration
  • Immunotherapy ≤ 3 weeks prior to registration
  • Radiation ≤ 2 weeks prior to registration.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy, patients with hepatitis B and C on active treatment, or those with acute hepatitis B and C not currently on treatment.
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Clinically significant cardiac arrhythmia
  • Bleeding disorder
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
  • Any other conditions that would limit compliance with study requirements.
  • History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Other active malignancy ≤ 3 years prior to registration.
  • EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
  • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
  • Unresolved toxicity from prior chemotherapy (subjects must be recovery to ≤ grade 1 toxicity from previous anticancer treatments or previous investigational agents).
  • Receiving any other investigational agent or device ≤ 14 days prior to registration.
  • Planning on receiving other medical, surgical, or radiological cancer treatments during the course of this study.
  • Evidence of untreated fluid retention at the time of registration (including, for example, peripheral edema, pleural effusion, or ascites on physical or radiological examination) or history of severe capillary leak syndrome.
  • Any other condition which the investigator believes would make participation in the study not acceptable.
  • Subjects with any active and/or symptomatic brain metastases or active primary central nervous system (CNS) and subjects with carcinomatosis meningitis are excluded.
  • NOTE: History of brain metastases treated by surgery and/or radiotherapy provided neurologically stable and off steroids ≥ 4 weeks prior to registration are allowed.
  • Grade 2 or greater neuropathy (excluding diagnosed carpal tunnel syndrome).
  • Use of concomitant medication that are known to be strong or moderate inhibitors or inducers of CYP3A4 and CYP2B6 ≤ 14 days prior to registration.
  • Use of concomitant medication that are known to be substrates of CYP3A4, CYP2B6, or transporters of OAT3, MATE1, MATE2-K ≤ 14 days prior to registration.
  • Corrected QT (QTc) prolongation based on QTc interval prior to registration of ≥ 470 ms using the Fridericia's formula (QTcF).
  • Confluent superficial keratitis, a cornea epithelial defect, a corneal ulcer or stromal opacity.
  • Significant electrolyte imbalance.
  • Significant uncontrolled congestive heart failure.
  • Symptomatic uncontrolled cardiac arrhythmia.
  • Genetic predisposition for long QT syndrome.
  • Subjects who are receiving concomitant QT prolonging medication.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials contact

507-293-6386

United States1 site, 1 recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Cancer Center Clinical Trials, 507-293-6386

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess and determine the maximum tolerated dose (MTD) for SCD1 inhibitor MTI-301 (MTI-301).

SECONDARY OBJECTIVES:

  1. 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:

  1. 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 24 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.

Being tested
Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo tissue and blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • SCD1 Inhibitor MTI-301Biological

    Also called 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

    Given PO

Study groups in NCT06911008
Study groupRoleWhat they receive
Treatment (MTI-301)ExperimentalPatients receive MTI-301 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 24 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Biological: SCD1 Inhibitor MTI-301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 days (1 cycle)

  2. 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.

    Measured: Up to 30 days after last dose of study treatment

Secondary outcomes (3)

  1. Objective response rate

    Will be defined as the proportion of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 during protocol treatment (up to maximum of 6 cycles of treatment) among treated patients.

    Measured: Up to 6 cycles (1 cycle = 28 days)

  2. Duration of response

    Will be defined as the time from the date of first documented CR or PR to the date of first documented disease progression or death due to all causes, whichever occurs first.

    Measured: Up to 1 year

  3. Progression free survival

    Will be defined as the time from the date of registration to the date of first documented disease progression or death due to all causes, whichever occurs first.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start7 Nov 2025
  3. Primary completion9 Apr 2027 (estimated)
  4. Study completion9 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911008
Sponsor's protocol ID
MC210103
Other IDs
NCI-2025-01930, 24-012791, MC210103, R44CA272064
Status last verified
Sep 2026
First submitted
28 Mar 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wong TL, Kong Y, Ma S. Lipid metabolism in cancer cells: Its role in hepatocellular carcinoma progression and therapeutic resistance. Hepatol Commun. 2025 Oct 21;9(11):e0837. doi: 10.1097/HC9.0000000000000837. eCollection 2025 Nov 1.

    PubMed 41118283

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: Up to 28 days (1 cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06911008, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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Clinical Trial NCT06911008 | AzTrials