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Can an experimental pill boost chemotherapy's power against stubborn uterine cancer?

NCT ID NCT07737795

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding an experimental drug called OK-1 to the standard chemotherapy paclitaxel can shrink tumors in people with advanced or recurrent endometrial cancer. Participants take OK-1 capsules twice daily along with weekly intravenous paclitaxel. The study aims to see if the combination is safe and how many patients respond to treatment.

What this could mean

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

Active substance
an experimental drug called OK-1 combined with the chemotherapy drug paclitaxel
What this could lead to
If it works, this combination could offer a new treatment option for people with recurrent endometrial cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits are uncertain. The combination may cause significant side effects, and not all patients may tolerate it.

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 66 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

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: * At least 18 years-of-age at the time of signature of the informed consent form (ICF). * Histologically documented carcinoma of the endometrium, including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed, or is refractory to curative therapy or established treatments. * Must have pre-treatment archival tissue. * Measurable disease by RECIST v1.1 is required for the phase 2 portion of the study. Patients with accessible disease are eligible for the safety lead in cohorts. Patients with biochemical recurrent disease only (ie Ca125 elevation or ctDNA elevation in absence of visible disease on CT scan are NOT eligible) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Adequate organ function, defined in study protocol. * Prior therapy: Patients must have received ≥1 platinum-based therapy in the recurrent/metastatic setting and not more than 5 prior lines of therapies. * Adjuvant therapy given for early stage, high risk endometrial cancer does NOT count as the line of qualifying platinum based chemotherapy unless disease recurrence is documented \< 12 months from completion. If \>12 months has elapsed, patients should receive another line of platinum based chemotherapy. * Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase \[PARP\] inhibitor, endocrine therapy or immune checkpoint inhibitor will be considered part of the preceding line of therapy. * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently) * Hormonal therapy will not be counted as a separate line of therapy. * Patients should have received an immune checkpoint inhibitor as part of a prior line of therapy unless contraindicated to participate in this trial. * If the Patient has a tumor that is HER2 3+, trastuzumab deruxtecan should have been used unless ineligible. * During the course of this clinical trial, if an antibody drug conjugate becomes available therapy for recurrent endometrial cancer, patients should be treated with that therapy unless ineligible * The patient must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information. * QTcF \< 470 msec Exclusion Criteria: * Patients who have received prior weekly paclitaxel for recurrent endometrial cancer. * Major surgical procedure within 28 days prior to registration, or anticipation of need for major surgical procedure during the study. Note: Placement of a vascular access device, thoracentesis, and/or paracentesis will not be considered major surgery. * Women who are pregnant or are unwilling to discontinue nursing. * Evidence of bleeding diathesis or clinically significant coagulopathy within the past 3 months. Patients are not excluded for past or current use of anticoagulation. * There is no prespecified washout from prior therapies. * Patients with adverse events related to prior therapies must have resolution to \< grade 1. Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. Note: Grade 2 neuropathy is neuropathy on one medication so patients may be eligible following discussions with the medical monitor. Additional exceptions include immune-related AEs such as adrenal insufficiency, hypothyroidism (controlled), endocrine-related toxicities due to checkpoint inhibitor treatment (can be corrected through hormone replacement therapy) and Grade 2 laboratory abnormalities that meet the eligibility requirements. * Patients currently taking and unwilling/unable to discontinue the use of drugs that are known to be strong/moderate inhibitors or inducers of CYP3A4, CYP2C8, CYP2C19, and CYP2C9. (Refer to Appendix III) * Comorbid Conditions: No active infection requiring parental antibiotics except for urinary tract infection. * No evidence of intra-abdominal abscess, abdominal/pelvic fistula, gastrointestinal perforation, or GI obstruction requiring gastrostomy tube. NOTE: required interval since last bowel obstruction: 30-day minimum for incomplete obstruction, resolved with conservative means; 6 months for fistula. Patients with a history of a large bowel obstruction that has been successfully diverted and do not meet the criteria for small bowel obstruction are eligible. * Patients with risk factors for torsade de pointes (TdP) such as clinically significant heart failure (defined as a known ejection fraction \< 50%), uncorrected grade 2 or greater hypokalemia, family history of long QT syndrome )

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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.

  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

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117, United States

More trials for these conditions

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