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.
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.
Pregnant persons
Nursing persons
Persons who are of childbearing potential who are unwilling to employ adequate contraception.
Oral
Single group
Biospecimen Collection
Procedure/SurgeryUndergo tissue and blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
SCD1 Inhibitor MTI-301
Biological/VaccineGiven PO
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.
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.
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.
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.
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.
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Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator
