This is an open-label, multicenter, exploratory Phase II study to evaluate the efficacy and safety of TR115, an EZH2 inhibitor, in patients with advanced solid tumors carrying ARID1A gene mutations. Approximately 50 participants will be enrolled into three cohorts: platinum-resistant ovarian clear cell carcinoma, endometrial cancer with prior immunotherapy failure, and other solid tumors including gastric and urothelial cancers. All participants will receive TR115 at 1200 mg orally twice daily in continuous 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint is objective response rate (ORR). Secondary endpoints include duration of response, progression-free survival, overall survival, disease control rate, and safety. Exploratory biomarker analyses will also be conducted.
Able to understand and provide written informed consent.
Age 18 to 70 years, inclusive.
Histologically or cytologically confirmed advanced solid tumor with ARID1A mutation.
Cohort 1: Platinum-resistant ovarian/fallopian tube/peritoneal clear cell carcinoma with disease progression after ≥1 prior platinum-based regimen. Cohort 2: Endometrial cancer with disease progression after ≥1 prior platinum-based regimen and prior immunotherapy failure or intolerance. Cohort 3: Other advanced solid tumors (including gastric cancer, urothelial carcinoma) with disease progression after ≥1 prior standard systemic therapy.
Prior treatment with EZH2 or EZH1/2 inhibitors resulting in disease progression (intolerance permitted).
Third-space fluid accumulation not controllable by drainage or other means.
Systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) within 14 days prior to first dose, except for inhaled or topical use.
Inability to swallow oral medication or conditions significantly affecting drug absorption.
Single group
TR115
DrugTR115 tablet, 200 mg per tablet, administered orally at a dose of 1200 mg twice daily (total 6 tablets per dose) with water. Each 28-day period constitutes one treatment cycle.
Objective Response Rate (ORR)
Duration of Response (DoR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Disease Control Rate (DCR)
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