Study Comparing Mocertatug Rezetecan with Chemotherapy for Endometrial Cancer After Previous Treatments

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07286331

This clinical trial is testing a new drug, mocertatug rezetecan (Mo-Rez), to see if it works better than standard chemotherapy for treating endometrial cancer in patients who have already received platinum-based chemotherapy and immunotherapy. The study also aims to understand the safety and side effects of Mo-Rez compared to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how effective and safe the new drug mocertatug rezetecan (Mo-Rez) is for treating endometrial cancer compared to the usual chemotherapy treatments. Researchers want to see if Mo-Rez can better manage the cancer and what side effects it might have compared to the standard care.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old and legally able to consent to participate.
  • Must have a confirmed diagnosis of endometrial cancer, including specific types like endometrioid, serous, clear cell, or carcinosarcoma.
  • Must have had 1 to 2 previous treatments for endometrial cancer, or up to 3 if one was given before or after surgery.
  • Must have cancer that has worsened after platinum-based chemotherapy and have received PD-1/PD-L1 therapy, unless unsuitable for such treatment.
  • Must have a platinum-free interval of less than 12 months if only treated with platinum-based therapy after surgery.
  • Must provide a tumor sample for testing a specific protein (B7-H4) before starting the study.
  • Must have at least one measurable tumor.
  • Must agree to use effective birth control during the study and for 8 months after the last dose if of childbearing potential.
  • Must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
  • Must be able to give informed consent and follow study requirements.
  • Must have a performance status indicating good overall health (ECOG 0 or 1).
  • Must have adequate organ function.

Exclusion Criteria

  • Cannot have certain types of uterine cancer like uterine sarcomas or neuroendocrine cancer.
  • Cannot have another cancer that has needed treatment in the last 3 years, except for certain skin cancers or in-situ cancers that have been treated.
  • Cannot have had a bone marrow or organ transplant.
  • Cannot have allergies to the study drugs or their components.
  • Cannot have untreated or worsening brain or CNS metastases.
  • Cannot have a history of lung disease or pneumonitis.
  • Cannot have unresolved side effects from previous treatments, except for certain conditions like hair loss or stable conditions.
  • Cannot have serious medical or psychiatric conditions that could interfere with the study.
  • Cannot have had major surgery or certain treatments recently.
  • Cannot have received certain investigational or anti-cancer drugs recently.
  • Cannot have received a live vaccine recently.
  • Cannot have certain infections like HIV with specific criteria, or active hepatitis B or C.
  • Cannot have significant heart or kidney conditions.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site35226BirminghamAlabama
GSK Investigational Site68114-4108OmahaNebraska

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.