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Colorectal Carcinoma (CRC)Phase 2NCT06129604

Pilot Window of Opportunity Trial (POET)

A Phase 2 study testing TPST-1495 in people with Colorectal Carcinoma (CRC) and Endometrial Carcinoma (EC), run by University of Oklahoma at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The proposed clinical trial with TPST-1495 can help people with two types of cancer, Endometrial Cancer (EC) and Colorectal Carcinoma (CRC), who need surgery. The investigator plans to evaluate how well TPST-1495 works against these cancers by checking blood samples and tumor tissues taken before and after the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TPST-1495
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
3 Apr 2024to 30 Sep 2026
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent signed and dated by the patient prior to the performance of any study- specific procedures.
  • At least 18 years of age at the time of signature of the informed consent form (ICF)
  • Histologically confirmed endometrial cancer or colorectal cancer of any stage; either newly diagnosed or recurrent cancer, however no prior chemotherapy or radiation will be allowed.
  • Must be candidates for surgical therapy.
  • Male or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two highly effective methods of contraception during the study treatment and for 3 months after the treatment termination visit. In addition, women of childbearing potential are required to undergo serum pregnancy testing at screening, and at the treatment termination visit.
  • Male study participants should refrain from sperm donation during study treatment and up to 3 months following the last dose of TPST-1495
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  • To have archival tumor tissue specimen available. Otherwise, patients should agree to have tumor biopsy to obtain sufficient tissue for histological assessment.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Life expectancy estimated to be > 12 weeks.
  • Adequate organ and marrow function as defined in protocol.

Who cannot join

  • Concurrent enrollment in another clinical study, unless it is an observational clinical study, a specimen-collection study, or the follow-up period of an interventional study.
  • Patients who used NSAID or COX-2 inhibitors with duration of 4 days or longer within 2 weeks prior to study treatment initiation.
  • Patients with past medical history (PMH) of allergy or hypersensitivity, GI bleed, or ulceration secondary to NSAID's or COX-2 inhibitors.
  • PMH of GI ulcer within one year of treatment initiation or history of untreated helicobacter's pylori infection. Subjects with history of treated helicobacter's pylori infection with confirmation of eradication are eligible.
  • PMH of diverticulitis or any GI bleed within 2 years of treatment initiation.
  • Heart failure is classified by New York Heart Association as Classification II, III or IV.
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  • Patients with history of MI or TIA/CVA will be excluded.
  • Active autoimmune disease or inflammatory disorders including inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease) requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids, or immunosuppressive drug) within 2 years prior to treatment initiation.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations including a history of substance abuse that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Subjects who are receiving anticoagulant therapy or considered to be at increased risk of bleeding (i.e., bleeding disorder or coagulopathy).
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
  • 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 should be included.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117

Other trials in United States

About this study

Official title: A Phase 2 Pilot Window of Opportunity Study of the EP2 and EP4 Receptors Inhibitor TPST-1495 in Patients With Endometrial Cancer or Colorectal Cancer Planning to Undergo Surgical Therapy

The proposed clinical trial with TPST-1495 can help people with two types of cancer, Endometrial Cancer (EC) and Colorectal Carcinoma (CRC), who need surgery. The investigator plans to evaluate how well TPST-1495 works against these cancers by checking blood samples and tumor tissues taken before and after the treatment to see if it is an effective treatment option to help the immune system fight against cancer.

Read the detailed description

TPST-1495, a dual antagonist targeting human prostaglandin E2 receptor subtypes EP2 and EP4, has shown promising safety and possesses potential immunomodulatory and antineoplastic properties in preclinical research. Based on previous clinical research, the investigator proposes that TPST-1495 treatment could offer anti-cancer benefits to endometrial cancer (EC) and colorectal cancer (CRC) patients.

This pilot window-of-opportunity study aims to assess the safety and biological effectiveness of administering 50mg TPST-1495 orally once daily for seven days, with discontinuation three days prior to surgical therapy, involving 10 evaluable patients, with five each from the EC and CRC groups, for a maximum total of 20 participants enrolled to ensure 10 evaluable patients.

Being tested
TPST-1495
Medical subject headings
Colorectal Neoplasms, Endometrial Neoplasms

What participants receive

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

  • TPST-1495Drug

    Eligible subjects will receive study treatment of 50mg TPST-1495 taken orally, once a day for 7 days prior and discontinued 3 days prior to scheduled surgery.

Study groups in NCT06129604
Study groupRoleWhat they receive
pilot window of opportunity trial of TPST-1495ExperimentalNot described
Receives: Drug: TPST-1495

What is being measured

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

  1. EP2 and EP4 receptor subtypes blood biomarker expression within the PGE2 signaling pathway.

    Blood samples from patients with EC and/or CRC will be assessed at screening(pre-dose) and post-surgery to evaluate the expression of EP2 and EP4 receptor biomarkers within the PGE2 signaling pathway, providing insights into impact of TPST-1495 on pharmacodynamic pathway changes.

    Measured: 1 years

  2. EP2 and EP4 receptor subtypes tumor biomarker expression within the PGE2 signaling pathway.

    Tumor samples from patient with EC and/or CRC will be assessed at screening (pre-dose) and post-surgery to evaluate the expression of EP2 and EP4 receptor biomarkers within the PGE2 signaling pathway, providing insights into impact of TPST-1495 on pharmacodynamic pathway changes.

    Measured: 1 years

Secondary outcomes (5)

  1. Antitumor Activity

    Number and percentage of participants with EC and/or CRC will be reported for anti-tumor activity of TPST-1495's, based on the measurement involving mean or median values of circulatory immune cells in blood samples and tumor tissues at screening(pre-dose) and post-surgery.

    Measured: 2 years

  2. Biological Efficacy

    Number and percentage of participants with EC and/or CRC will be assessed for biological efficacy of TPST-1495's, based on the measurement involving mean or median values of circulatory immune cells in blood samples and tumor tissues at screening (pre-dose) and post-surgery.

    Measured: 2 years

  3. Rate of dynamic changes in immune cells

    This measure involves comparing the mean or median values of pre-blood and post-blood samples to assess the dynamic changes in immune cell populations. Flow cytometry will be utilized to examine alterations in immune cell composition following treatment.

    Measured: 2 years

  4. Rate of dynamic Changes in Inflammatory Cytokines and Chemokines

    This outcome measure focuses on comparing the mean or median values of pre-blood and post-blood samples to evaluate dynamic changes in inflammatory cytokines and chemokines. Flow cytometry will be employed to assess variations in the levels of these important biomolecules in response to treatment.

    Measured: 2 years

  5. Incidences of TPST-1495 drug therapy based potential adverse events

    It utilizes CTCAE v5.0 to systematically report and assess the incidence and the severity of potential adverse events that patients may experience during treatment, ensuring consistent and reliable safety assessment.

    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 posted13 Nov 2023
  2. Study start3 Apr 2024
  3. Primary completion22 Aug 2025
  4. Study completion30 Sep 2026 (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
Model description
This pilot window of opportunity study proposes to evaluate the safety and biological efficacy of 50mg TPST-1495 in patients with EC or CRC undergoing surgical therapy.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129604
Sponsor's protocol ID
OU-SCC-POET
Status last verified
Jul 2026
First submitted
2 Oct 2023
Last updated
15 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 TPST-1495 in people with Colorectal Carcinoma (CRC) and Endometrial Carcinoma (EC), 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 10 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 15 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EP2 and EP4 receptor subtypes blood biomarker expression within the PGE2 signaling pathway. (time frame: 1 years). The study lists 2 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 NCT06129604.

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 15 Jul 2026.

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