Can an experimental pill boost chemotherapy's power against stubborn uterine cancer?
NCT ID NCT07737795
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 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: * 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 )
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.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Shorter, personalized radiation may target endometrial cancer with fewer side effects
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a Weight-Loss drug and an IUD treat early uterine cancer without surgery?
- Your gut bacteria may hold the key to whether immunotherapy works
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can an oral drug that starves tumors help Hard-to-Treat cancers?