Pilot Window of Opportunity Trial (POET) (NCT06129604) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pilot Window of Opportunity Trial (POET)
United States10 participantsStarted 2024-04-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EP2 and EP4 receptor subtypes blood biomarker expression within the PGE2 signaling pathway.
Timeframe: 1 years
2
EP2 and EP4 receptor subtypes tumor biomarker expression within the PGE2 signaling pathway.
. 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.
Exclusion criteria
. 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.