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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Pregnant persons

Nursing persons

Persons who are of childbearing potential who are unwilling to employ adequate contraception.

Oral

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Questionnaire Administration
  • SCD1 Inhibitor MTI-301

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator