臨床研究等提出・公開システム

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

A PHASE I STUDY OF MINT91 IN COMBINATION WITH OTHER ANTI-CANCER DRUGS IN PATIENTS WITH SOLID TUMORS

Yamamoto Noboru

Department of Experimental Therapeutics, National Cancer Center Hospital

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Recruiting

April. 01, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

Locally advanced or metastatic solid tumors

MINT91: Oral administration
Gemcitabine: Intravenous infusion

safety, efficacy, exploratory, phamacokinetics
Observation/test

safety, efficacy, exploratory, phamacokinetics
Observation/test

+81-3-3542-2511

Feb. 26, 2025

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Australia