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TPST-1495 for Endometrial and Colorectal Cancers

Phase 2

Recruiting

Led By Susanna Ulahannan, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age at the time of signature of the informed consent form (ICF)

Histologically confirmed endometrial cancer or colorectal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study if TPST-1495 can help people with Endometrial Cancer and Colorectal Carcinoma who need surgery to fight cancer. Blood/tissue samples will be checked to see if it's effective.

Who is the study for?

The POET trial is for adults with confirmed endometrial or colorectal cancer who are fit enough for surgery and have a life expectancy over 12 weeks. They must be able to consent, have tumor tissue available, and use two forms of contraception if of childbearing potential. Exclusions include other clinical study participation, recent NSAID/COX-2 inhibitor use, certain medical histories like heart failure or autoimmune diseases, uncontrolled illnesses, bleeding risks, and any condition affecting protocol adherence.Check my eligibility

What is being tested?

This pilot trial tests TPST-1495's effectiveness in treating endometrial cancer (EC) and colorectal carcinoma (CRC). Patients will receive TPST-1495 before their scheduled surgeries while the researchers monitor blood samples and tumor tissues to assess how well it helps the immune system combat these cancers.See study design

What are the potential side effects?

While specific side effects of TPST-1495 aren't listed here, common side effects from similar treatments may include immune-related reactions such as inflammation in various organs, fatigue, digestive issues like diarrhea or nausea; skin reactions; hormonal changes; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is either in the lining of the uterus or in the colon/rectum.

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I am using two forms of birth control, including a barrier method, and will not donate sperm while in the study.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am eligible for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Antitumor Activity

Biological Efficacy

Incidences of TPST-1495 drug therapy based potential adverse events

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: pilot window of opportunity trial of TPST-1495Experimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,913 Total Patients Enrolled

Susanna Ulahannan, MDPrincipal InvestigatorOU Health Stephenson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration given clearance to TPST-1495's initial feasibility study?

"Our team at Power rated the security of pilot window of opportunity trial of TPST-1495 a two due to its Phase 2 status, which indicates that there is evidence supporting safety but not efficacy."

Answered by AI

What are the anticipated outcomes of this research endeavor?

"This clinical trial, which will span approximately 1 year and include 100 participants across 3 sites, is aimed at assessing the expression of EP2 and EP4 receptor subtypes within the PGE2 signaling pathway. Secondary objectives involve evaluating dynamic changes in immune cells via flow cytometry to measure anti-tumor activity; additionally, this study also intends to assess alterations in inflammatory cytokines/chemokines by comparing pre-blood and post-blood samples."

Answered by AI

Are there any spots available for this research endeavor?

"Clinicaltrials.gov indicates that this trial is not recruiting participants at the time of writing, as it was first posted on January 1st, 2024 and most recently edited in November 8th, 2023. However, there are 3,864 other clinical trials actively seeking enrolment from patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Window of Opportunity Trial (POET)

2024. "Pilot Window of Opportunity Trial (POET)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06129604.