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Endometrial CancerPhase 2NCT07737795

Evaluating the Addition of OK-1 Weekly Paclitaxel in Patients With Endometrial Cancer

A Phase 2 study testing OK-1 & Paclitaxel in people with Endometrial Cancer, run by University of Oklahoma at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate whether treatment with the investigational drug OK-1 in combination with paclitaxel can reduce tumor burden in patients with advanced or recurrent endometrial cancer (A/R-EC). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
OK-1 & Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Aug 2026to Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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 )

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lead Gynecology Oncology Nurse contact

572-244-0111

SCC-IIT-Office@ouhsc.edu

United States1 site

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117

    Kathleen Moore, MD, Katmoore@unmc.edu

Other trials in United States

About this study

Official title: A Single Arm Phase 2 Trial With a Safety Lead in Evaluating the Addition of OK-1 to Weekly Paclitaxel in Patients With Recurrent Endometrial Cancer

The purpose of this study is to evaluate whether treatment with the investigational drug OK-1 in combination with paclitaxel can reduce tumor burden in patients with advanced or recurrent endometrial cancer (A/R-EC).

Read the detailed description

Participants will receive OK-1 capsules by mouth twice daily in continuous 21-day treatment cycles. Paclitaxel will be administered by intravenous (IV) infusion once weekly during each 21-day cycle. A combined total of 66 patients will participate in this study, with the initial safety lead-in cohort involving 30 patients, followed by 36 new patients enrolled in the phase 2 arm.

Treatment cycles will continue until the participant, the treating physician, or the study team determines that continued participation is no longer appropriate due to disease progression, unacceptable side effects, withdrawal of consent, or another clinical reason. Throughout the study, participants will undergo regular laboratory testing and clinical examinations to monitor their health and treatment response. Participation in the study is expected to last for up to one year.

Being tested
OK-1 & Paclitaxel
Keywords
OK-1, A/R-EC, ShetA2
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OK-1 & PaclitaxelDrug

    OK-1 capsules will be administered orally at 3.5-4.5 mg/kg twice a day during a 21-day cycle (3 weeks on, one week off in a 28-day cycle)

    Other Names:

    • NSC 726189

    Paclitaxel will be administered 60-70 mg/m2 IV on Day 1,8 and 15 (3 weeks on, one week off in a 28-day cycle)

Study groups in NCT07737795
Study groupRoleWhat they receive
Phase 2 CohortExperimentalOK-1 (oral, BID) 28-days cycle. Weekly Paclitaxel (IV) 21-days cycle.
Receives: Drug: OK-1 & Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Proportion of Patients Who Safely Tolerate The Combination of OK-1 and Paclitaxel

    Quantitative assessment of patients who experienced >gr.3 AEs during OK-1 in combination with a weekly paclitaxel regimen using CTCAE v6

    Measured: 12 Months

  2. Proportion of Patients Who Successfully Completed The Safety Lead-In Phase and Tolerated OK-1 In Combination With Paclitaxel.

    Completion of safety lead-in with an established phase 2 dose for OK-1 combination with weekly intravenous paclitaxel

    Measured: 1 Year

  3. Proportion of Participants Overrall Response Rate To OK-1 In Comination With Paclitaxel

    To quantitatively evaluate the overall response rate (ORR) in the Phase 2 cohort by determining the proportion of participants who achieve a complete response (CR) or partial response (PR) to treatment.

    Measured: 2 Years

Secondary outcomes (3)

  1. Participants Duration of Response To OK-1 In Combination With Paclitaxel

    Assess the number of days from the onset of treatment-induced response to the subsequent progression of the disease or death, or last time of follow-up

    Measured: 2 years

  2. Assess Progression Free Survival In Participants Who Tolerated OK-1 In Combination With Paclitaxel

    Determine the number of days from the start of study treatment to date of imaging-confirmed study progression, death, or last time of follow-up

    Measured: 2 years

  3. Overall Survival at 12 Months

    Assess the percentage of patients alive at 12 months post-enrollment.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07737795
Sponsor's protocol ID
OU-SCC-OkGyn1Endo
Other IDs
P50CA265793
Status last verified
Jul 2026
First submitted
27 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OK-1 & Paclitaxel in people with Endometrial Cancer, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lead Gynecology Oncology Nurse (572-244-0111, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Proportion of Patients Who Safely Tolerate The Combination of OK-1 and Paclitaxel (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07737795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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