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Not yet recruitingNCT07793318Updated Aug 28, 2026

TR115 in ARID1A-Mutated Advanced Solid Tumors

A Phase 2 interventional study of TR115 in Ovarian Clear Cell Carcinoma, Endometrial Cancer and Stomach Cancer Recurrent, sponsored by Tarapeutics Science Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Tarapeutics Science Inc. · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 170 studies in Endometrial Neoplasms with a site in China — 98 open to participants now, 120 under way, 21 of them phase 3. Endometrial Neoplasms · China.

Planned enrollment
101st of 140
50 · median 115
Started
2026
with 17 others
Phase 2
41 of 170
29 open now
Primary completion
2028-05
later than 93 of 119 live
Registered
163rd of 170
by date

Among the 170 studies in Endometrial Neoplasms with a site in China, this one is the 101st largest by planned enrollment of the 140 interventional ones that give a count, is one of 18 that started in 2026, is one of 41 in phase 2, reaches primary completion later than 93 of the 119 other live ones, and was the 163rd registered.

Endometrial Neoplasms

1,426 studies on the registry are indexed under Endometrial Neoplasms; 471 are open to participants now.

Browse Endometrial Neoplasms studies →

Open to participants now

98 of the 170 studies in Endometrial Neoplasms with a site in China are open now. Recruiting first, the newest first:

93 more — sign in →

All 98 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 357 Endometrial Neoplasms studies recruiting now, 267 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Ovarian Clear Cell Carcinoma
  • Endometrial Cancer
  • Stomach Cancer Recurrent
  • Urinary Bladder Cancer
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to understand and provide written .
  • Age 18 to 70 years, inclusive.
  • 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.
  • performance status 0-1.
  • ≥3 months.
  • At least one per v1.1.
  • Adequate organ function: ≥1.5×10⁹/L, ≥100×10⁹/L, ≥100 g/L (no growth factor or transfusion support within 14 days prior to first dose), ≤1.5×, /AST ≤2.5×ULN (≤5×ULN if liver ), ≥50 mL/min, ≥50%, \<450 ms (male) or \<470 ms (female).
  • Willing to provide archival or fresh tumor tissue for biomarker analysis.
  • Male and female participants of must agree to use medically approved during the study and for 6 months after the last dose.

Exclusion criteria

Exclusion Criteria:

  • 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 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.
  • Active infection requiring systemic therapy.
  • Active or C requiring treatment, or infection.
  • Active disease requiring systemic therapy.
  • Significant cardiovascular disease (e.g., myocardial infarction within 6 months, Class III/IV heart failure, uncontrolled arrhythmia).
  • Pregnancy, lactation, or positive pregnancy test.
  • Other primary 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 ( v6.0), except alopecia or peripheral neuropathy Grade ≤2.
  • Use of strong or moderate 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.
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    TR115 tablet

    Drug: TR115

Interventions

  • DrugTR115

    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.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Duration of Response (DoR)

    Time frame: up to approximately 36 months

  2. Progression-Free Survival (PFS)

    Time frame: up to approximately 36 months

  3. Overall Survival (OS)

    Time frame: up to approximately 36 months

  4. Disease Control Rate (DCR)

    Time frame: up to approximately 24 months.

  5. Incidence and severity of adverse events (AEs)

    Time frame: from first dose through 30 days after last dose

  6. serious adverse events (SAEs)

    Time frame: first dose through 30 days after last dose

  7. laboratory abnormalities graded by CTCAE v6.0,

    Time frame: first dose through 30 days after last dose

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2028, 19 months later.

Of 139 phase 2 interventional studies under Endometrial Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 115. This study's planned 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Aug 28, 2026
StartEst.
Sep 20, 2026
Primary completionEst.
May 1, 2028
CompletionEst.
May 1, 2029
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793318
Lead sponsor
Tarapeutics Science Inc.
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
May 1, 2028 (estimated)
Completion
May 1, 2029 (estimated)
Last update
Aug 28, 2026

Study contacts

Yang Shu
Contact
shuyang@tarapeutics.com
86 13918983465

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: TR115

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