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TR115 in ARID1A-Mutated Advanced Solid Tumors
Sponsor: Tarapeutics Science Inc.
Summary
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.
Official title: An Open-Label, Multicenter, Phase II Exploratory Study to Evaluate the Efficacy and Safety of TR115 in Patients With ARID1A-Mutated Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-09-20
Completion Date
2029-05-01
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
TR115
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.
Locations (1)
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China