Ovarian Clear Cell CarcinomaPhase 2NCT07793318
TR115 in ARID1A-Mutated Advanced Solid Tumors
A Phase 2 study testing TR115 in people with Ovarian Clear Cell Carcinoma and Endometrial Cancer, run by Tarapeutics Science Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ovarian Clear Cell Carcinoma, Endometrial Cancer, Stomach Cancer Recurrent
- What is being tested?
- TR115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- ECOG performance status 0-1.
- Life expectancy ≥3 months.
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- At least one measurable lesion per RECIST v1.1.
- Adequate organ function: ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥100 g/L (no growth factor or transfusion support within 14 days prior to first dose), TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN (≤5×ULN if liver metastasis), CrCl ≥50 mL/min, LVEF ≥50%, QTcF <450 ms (male) or <470 ms (female).
- Willing to provide archival or fresh tumor tissue for biomarker analysis.
- Male and female participants of childbearing potential must agree to use medically approved contraception during the study and for 6 months after the last dose.
Who cannot join
- 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.
- Known central nervous system (CNS) involvement.
- Tumor invasion or encasement of major vessels.
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- Active infection requiring systemic therapy.
- Active hepatitis B or C requiring treatment, or HIV infection.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Significant cardiovascular disease (e.g., myocardial infarction within 6 months, NYHA Class III/IV heart failure, uncontrolled arrhythmia).
- Pregnancy, lactation, or positive pregnancy test.
- Other primary malignancy within 5 years, except cured non-melanoma skin cancer, carcinoma in situ, or thyroid carcinoma.
- Prior anti-tumor therapy-related adverse events not recovered to ≤Grade 1 (CTCAE v6.0), except alopecia or peripheral neuropathy Grade ≤2.
- Use of strong or moderate CYP3A4 inhibitors/inducers within 14 days prior to first dose.
- Any other condition that in the investigator's opinion makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, MD, PhD, 8613601772486, wu.xh@fudan.edu.cn
About this study
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
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.
- Conditions
- Ovarian Clear Cell Carcinoma, Endometrial Cancer, Stomach Cancer Recurrent, Urinary Bladder Cancer
- Being tested
- TR115
- Medical subject headings
- Endometrial Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR115Drug
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 group | Role | What they receive |
|---|---|---|
| TR115 tablet | Experimental | Not described Receives: Drug: TR115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Up to approximately 24 months
Secondary outcomes (7)
Duration of Response (DoR)
Measured: up to approximately 36 months
Progression-Free Survival (PFS)
Measured: up to approximately 36 months
Overall Survival (OS)
Measured: up to approximately 36 months
Disease Control Rate (DCR)
Measured: up to approximately 24 months.
Incidence and severity of adverse events (AEs)
Measured: from first dose through 30 days after last dose
serious adverse events (SAEs)
Measured: first dose through 30 days after last dose
laboratory abnormalities graded by CTCAE v6.0,
Measured: first dose through 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarapeutics Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793318
- Sponsor's protocol ID
- TR115-CN-PII-01
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07793318
- Acronym / sponsor ID
- TR115-CN-PII-01
- Conditions
- Ovarian Clear Cell Carcinoma, Endometrial Cancer, Stomach Cancer Recurrent, Urinary Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tarapeutics Science Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TR115 tablet | Experimental | Drug: TR115 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- ECOG performance status 0-1.
Key exclusion criteria (15 listed)
- 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.
- Known central nervous system (CNS) involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR115TR115 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. | Drug | TR115 tablet |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TR115 in people with Ovarian Clear Cell Carcinoma and Endometrial Cancer, run by Tarapeutics Science Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Shu (86 13918983465, shuyang@tarapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.