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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
EP2 and EP4 receptor subtypes blood biomarker expression within the PGE2 signaling pathway.
Blood samples from patients with EC and/or CRC will be assessed at screening(pre-dose) and post-surgery to evaluate the expression of EP2 and EP4 receptor biomarkers within the PGE2 signaling pathway, providing insights into impact of TPST-1495 on pharmacodynamic pathway changes.
Time frame: 1 years
EP2 and EP4 receptor subtypes tumor biomarker expression within the PGE2 signaling pathway.
Tumor samples from patient with EC and/or CRC will be assessed at screening (pre-dose) and post-surgery to evaluate the expression of EP2 and EP4 receptor biomarkers within the PGE2 signaling pathway, providing insights into impact of TPST-1495 on pharmacodynamic pathway changes.
Time frame: 1 years
Antitumor Activity
Number and percentage of participants with EC and/or CRC will be reported for anti-tumor activity of TPST-1495's, based on the measurement involving mean or median values of circulatory immune cells in blood samples and tumor tissues at screening(pre-dose) and post-surgery.
Time frame: 2 years
Biological Efficacy
Number and percentage of participants with EC and/or CRC will be assessed for biological efficacy of TPST-1495's, based on the measurement involving mean or median values of circulatory immune cells in blood samples and tumor tissues at screening (pre-dose) and post-surgery.
Time frame: 2 years
Rate of dynamic changes in immune cells
This measure involves comparing the mean or median values of pre-blood and post-blood samples to assess the dynamic changes in immune cell populations. Flow cytometry will be utilized to examine alterations in immune cell composition following treatment.
Time frame: 2 years
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Rate of dynamic Changes in Inflammatory Cytokines and Chemokines
This outcome measure focuses on comparing the mean or median values of pre-blood and post-blood samples to evaluate dynamic changes in inflammatory cytokines and chemokines. Flow cytometry will be employed to assess variations in the levels of these important biomolecules in response to treatment.
Time frame: 2 years
Incidences of TPST-1495 drug therapy based potential adverse events
It utilizes CTCAE v5.0 to systematically report and assess the incidence and the severity of potential adverse events that patients may experience during treatment, ensuring consistent and reliable safety assessment.
Time frame: 2 years