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NOT YET RECRUITING
NCT07793318
PHASE2

TR115 in ARID1A-Mutated Advanced Solid Tumors

Sponsor: Tarapeutics Science Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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