TPST-1495 for Endometrial and Colorectal Cancers

Recruiting at 1 trial location

Overseen By Susanna Ulahannan, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Oklahoma

Must not be taking: NSAIDs, COX-2 inhibitors, Anticoagulants

Disqualifiers: Heart failure, MI, TIA/CVA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called TPST-1495 for endometrial and colorectal cancers. Researchers will analyze blood and tumor samples before and after treatment to determine if TPST-1495 can help the immune system fight these cancers. Individuals with endometrial or colorectal cancer who need surgery, have not undergone chemotherapy or radiation, and can provide tumor samples might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important cancer research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used NSAIDs or COX-2 inhibitors for 4 days or longer within 2 weeks before starting the study treatment. If you are on anticoagulant therapy, you may not be eligible to participate.

Is there any evidence suggesting that TPST-1495 is likely to be safe for humans?

Research has shown that TPST-1495 is generally safe for people. In one study, participants with cancer experienced tumor shrinkage and well-controlled disease when using TPST-1495 alone or with pembrolizumab. Earlier studies also suggest that TPST-1495 could offer immune system benefits. Although specific side effects weren't detailed, the ongoing testing indicates it is well-tolerated so far. Prospective participants should discuss any concerns with the study team or their doctor to understand how this treatment might work for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometrial and colorectal cancers?

Researchers are excited about TPST-1495 because it represents a new approach for treating endometrial and colorectal cancers. Unlike the standard treatments, which often involve chemotherapy or targeted therapies like bevacizumab and pembrolizumab, TPST-1495 works by targeting the prostaglandin pathway, specifically inhibiting the EP2 and EP4 receptors. This novel mechanism is believed to reduce inflammation and potentially slow tumor growth in a way that current treatments do not. This could mean more effective management of these cancers with potentially fewer side effects, offering hope for improved patient outcomes.

What evidence suggests that TPST-1495 might be an effective treatment for endometrial and colorectal cancers?

Research shows that TPST-1495, which participants in this trial will receive, may help treat endometrial and colorectal cancers. In a previous study, a patient with endometrial cancer experienced a 22% reduction in tumor size. TPST-1495 has also been linked to delaying cancer progression. This treatment targets a protein called COX-2, often found in high amounts in tumors, enhancing the immune system's ability to fight cancer. These findings suggest that TPST-1495 could be a helpful option for patients with these types of cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Susanna Ulahannan, MD

Principal Investigator

OU Health Stephenson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You must sign a form agreeing to take part in the study before any study-related tests or procedures can be done.

Your doctor expects you to live for more than 12 weeks.

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

Exclusion Criteria

I have taken NSAIDs or COX-2 inhibitors in the last 2 weeks.

My heart condition limits my physical activity.

I have had allergies, stomach bleeds, or ulcers from pain relievers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 50mg TPST-1495 orally once daily for seven days, with discontinuation three days prior to surgical therapy

1 week

Daily administration

Surgery

Participants undergo surgical therapy after the treatment phase

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

2 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• TPST-1495

Trial Overview 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.

How Is the Trial Designed?

Group I: pilot window of opportunity trial of TPST-1495 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3107

A phase 1 study of TPST-1495 as a single agent and in ... In a subject with endometrial cancer with 22% tumor shrinkage and 222+ days on combination therapy paired biopsies showed high COX-2 expression ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06129604

NCT06129604 | Pilot Window of Opportunity Trial (POET) 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, ...

3. ir.tempesttx.com ir.tempesttx.com/news-releases/news-release-details/tempest-present-phase-1-monotherapy-and-combination-data-asco

News Release Details ... • Data show tumor shrinkage and prolonged disease control in both monotherapy and in combination with pembrolizumab.

4. cancer.gov cancer.gov/clinicaltrials/NCI-2024-05657

An Investigational Drug (TPST-1495) for the Treatment of ... This phase II trial tests how well TPST-1495 works in treating patients with endometrial cancer or colorectal cancer planning to undergo surgical therapy.

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06129604/

Trial | NCT06129604 Based on previous clinical research, the investigator proposes that TPST-1495 treatment could offer anti-cancer benefits to endometrial cancer (EC) and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04344795

Phase 1a/1b Study of TPST-1495 as a Single Agent and in ... This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07101

Phase 1a/1b Study of TPST-1495 as a Single Agent and in ... This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single ...