Pilot Window of Opportunity Trial (POET)

NCT06129604 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OU-SCC-POET
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 treatment to see if it is an effective treatment option to help the immune system fight against cancer.

Conditions

Endometrial Carcinoma (EC); Colorectal Carcinoma (CRC)

Outcome Measures

Primary Outcomes (2)

• 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.

  1 years

• 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.

  1 years

Secondary Outcomes (5)

• Antitumor Activity

  2 years

• Biological Efficacy

  2 years

• Rate of dynamic changes in immune cells

  2 years

• Rate of dynamic Changes in Inflammatory Cytokines and Chemokines

  2 years

• Incidences of TPST-1495 drug therapy based potential adverse events

  2 years

Study Arms (1)

pilot window of opportunity trial of TPST-1495

EXPERIMENTAL

Drug: TPST-1495

Interventions

TPST-1495 DRUG

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.

pilot window of opportunity trial of TPST-1495

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Susanna Ulahannan, MD

  OU Health Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: November 13, 2023
• Study Start: April 3, 2024
• Primary Completion: August 22, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)