TR115 in ARID1A-Mutated Advanced Solid Tumors

Sponsor
Tarapeutics Science Inc.
Study ID
NCT07793318
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Endometrial Cancer
  • Ovarian Clear Cell Carcinoma
  • Stomach Cancer Recurrent
  • Urinary Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TR115 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 20, 2026
Status verified
Aug 2026
Primary completion
May 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TR115 tablet

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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