Can a pill target cancers with a specific gene flaw?

NCT ID NCT07793318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This phase II trial tests an experimental drug called TR115 in people with advanced solid tumors that have a mutation in the ARID1A gene. The study includes patients with platinum-resistant ovarian clear cell carcinoma, endometrial cancer that failed immunotherapy, and other tumors like gastric or bladder cancer. Participants take TR115 as a tablet twice daily in 28-day cycles. The main goal is to see if the drug shrinks tumors, with additional checks on how long the effect lasts and how safe the drug is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TR115, an experimental EZH2 inhibitor taken as a tablet by mouth
What this could lead to
If TR115 works, it could offer a new treatment option for people with advanced cancers that carry an ARID1A mutation, especially those who have run out of standard options.
What could go wrong
This is an early-phase trial with only 50 participants, so the drug may not shrink tumors or improve survival. Side effects are possible, and the results may not apply to all patients with these cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. 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 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. * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Endometrial cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Centre

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.