Mayo Clinic
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.
PRIMARY OBJECTIVE: I. To assess and determine the maximum tolerated dose (MTD) for SCD1 inhibitor MTI-301 (MTI-301). SECONDARY OBJECTIVES: I. 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: I. 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…
Inclusion Criteria: * 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 (obtaine…
Undergo tissue and blood sample collection
Undergo CT or PET/CT
Undergo MRI
Undergo PET/CT
Ancillary studies
Given PO
Arctuva estimate
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