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RecruitingLast updated: 1 April 2026

MIT101CT: Evaluating a medicine called MINT91 when given in combination with other anti-cancer drugs for treatment of locally advanced, recurrent or metastatic solid cancerA PHASE I, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND COHORT EXPANSION STUDY OF MINT91 IN COMBINATION WITH OTHER ANTI-CANCER DRUGS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

MIT101CT

Clinical summary

Summary

Patients receive MINT91, an oral drug, in combination with Gemcitabine chemotherapy, given intravenously (via IV), in all parts of the study.

The study aims to determine the safety and tolerability of MINT91 in combination with gemcitabine for patients with advanced/recurrent or metastatic solid tumours. This dose escalation study is split into four parts:

  • Part A is purely dose escalation
  • Part B will be backfill in patients with solid tumours with a specific genetic alteration
  • Part C will be backfill in patients with high grade serous ovarian cancer
  • Part D will be an expansion cohort for patients with platinum-resistant ovarian cancer that have not previously received gemcitabine

Conditions

This trial is treating people with locally advanced, recurrent or metastatic solid cancers

Eligibility

Inclusion

  • Age >= 18 years
  • ECOG Performance Status 0 or 1
  • Adequate hematologic and end organ function
  • Histologically or cytologically confimed locally advanced, recurrent, or metastatic solid tumor
  • Measurable disease per RECIST v1.1
  • Able to take oral medication (Part A)
  • Standard therapy ineffective, unsuitable, or not established (Part B)
  • No prior gemcitabine treatment (Part C, D)
  • No prior gemcitabine treatment
  • Diagnosed with platinum-resistant ovarian cancer (For Part C, high-grade serous subtype, for Part D, any histological subtype)
  • =< 2 prior lines of systemic anticancer therapy for platinum-resistant ovarian cancer
  • No prior gemcitabine treatment

Exclusion

  • History of severe allergy, anaphylaxis, or hypersensitivity to MINT91 or gemcitabine
  • Primary CNS malignancy, untreated CNS metastases requiring anti-tumor therapy, or active CNS metastases
  • Severe uncontrolled systemic disease or history/presence of interstitial lung disease
  • NYHA Class II or higher heart disease, myocardial infarction, unstable arrhythmia, unstable angina, or history within 3 months prior to enrollment

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • JRCT2031240713

Trial sponsor

Chugai Pharmaceutical Co., Ltd.

Scientific Title

A PHASE I, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND COHORT EXPANSION STUDY OF MINT91 IN COMBINATION WITH OTHER ANTI-CANCER DRUGS IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

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