Locally advanced or metastatic solid tumors
Conditions
Interventions
MINT91: Oral administration
Gemcitabine: Intravenous infusion
Sponsors
Yamamoto Noboru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, efficacy, exploratory, phamacokinetics Observation/test | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, exploratory, phamacokinetics Observation/test | — |
Countries
Australia, Japan
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed