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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
TR115 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.
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of Response (DoR)
Time frame: up to approximately 36 months
Progression-Free Survival (PFS)
Time frame: up to approximately 36 months
Overall Survival (OS)
Time frame: up to approximately 36 months
Disease Control Rate (DCR)
Time frame: up to approximately 24 months.
Incidence and severity of adverse events (AEs)
Time frame: from first dose through 30 days after last dose
serious adverse events (SAEs)
Time frame: first dose through 30 days after last dose
laboratory abnormalities graded by CTCAE v6.0,
Time frame: first dose through 30 days after last dose
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