Can a pill target cancers with a specific gene flaw?
NCT ID NCT07793318
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200032, China
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- Can a new drug shrink advanced solid tumors?