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
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.
• Written informed consent signed and dated by the patient prior to the performance of any study- specific procedures.
• At least 18 years of age at the time of signature of the informed consent form (ICF)
• Histologically confirmed endometrial cancer or colorectal cancer of any stage; either newly diagnosed or recurrent cancer, however no prior chemotherapy or radiation will be allowed.
• Must be candidates for surgical therapy.
• Male or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two highly effective methods of contraception during the study treatment and for 3 months after the treatment termination visit. In addition, women of childbearing potential are required to undergo serum pregnancy testing at screening, and at the treatment termination visit.
• Male study participants should refrain from sperm donation during study treatment and up to 3 months following the last dose of TPST-1495
• To have archival tumor tissue specimen available. Otherwise, patients should agree to have tumor biopsy to obtain sufficient tissue for histological assessment.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Life expectancy estimated to be \> 12 weeks.
• Adequate organ and marrow function as defined in protocol.