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

Trial Summary

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.

What is the purpose of this trial?

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.

Research Team

Susanna Ulahannan, MD

Principal Investigator

OU Health Stephenson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+