NCT06129604

Pilot Window of Opportunity Trial (POET)

A Phase 2 Pilot Window of Opportunity Study of the EP2 and EP4 Receptors Inhibitor TPST-1495 in Patients With Endometrial Cancer or Colorectal Cancer Planning to Undergo Surgical Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TPST-1495, a dual antagonist targeting human prostaglandin E2 receptor subtypes EP2 and EP4, has shown promising safety and possesses potential immunomodulatory and antineoplastic properties in preclinical research. Based on previous clinical research, the investigator proposes that TPST-1495 treatment could offer anti-cancer benefits to endometrial cancer (EC) and colorectal cancer (CRC) patients. 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, with discontinuation three days prior to surgical therapy, involving 10 evaluable patients, with five each from the EC and CRC groups, for a maximum total of 20 participants enrolled to ensure 10 evaluable patients.

Conditions

• Colorectal Carcinoma (CRC)
• Endometrial Carcinoma (EC)

Interventions

Type	Name	Description
DRUG	TPST-1495	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.

Timeline

• Start date: 2024-04-03
• Primary completion: 2025-08-22
• Completion: 2026-06-30
• First posted: 2023-11-13
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study