OncoMatch/Clinical Trials/NCT06911008
MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers
Is NCT06911008 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SCD1 Inhibitor MTI-301 for metastatic malignant solid neoplasm.
Treatment: SCD1 Inhibitor MTI-301 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard-of-care therapy
refractory to or intolerant of existing, standard-of-care therapy(ies), known to provide clinical benefit for their condition
Cannot have received: major surgery
Major surgery ≤ 3 weeks prior to registration
Cannot have received: chemotherapy
Chemotherapy ≤ 2 weeks prior to registration
Cannot have received: immunotherapy
Immunotherapy ≤ 3 weeks prior to registration
Cannot have received: radiation therapy
Radiation ≤ 2 weeks prior to registration
Cannot have received: investigational agent or device
Receiving any other investigational agent or device ≤ 14 days prior to registration
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's syndrome); ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Cardiac function
Prothrombin time (PT)/INR/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
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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