Study on T-regulatory Cell Depletion with E7777 and Pembrolizumab for Recurrent or Metastatic Solid Tumors

Sponsor: Alexander B Olawaiye, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05200559

Provider View

This clinical trial is exploring a new treatment combining E7777 and pembrolizumab to target and reduce certain immune cells in patients with recurrent or metastatic solid tumors. The study aims to find out if this combination can improve outcomes for patients with limited treatment options.

Patient Parameters

Program Overview

Epithelial ovarian cancer is a serious type of cancer affecting many women, with a high rate of recurrence and low survival rates. This study focuses on a new treatment approach for patients with recurrent, platinum-resistant ovarian cancer and other solid tumors. The trial will test a combination of E7777, which targets specific immune cells, and pembrolizumab, an immunotherapy drug. The study will enroll patients in two phases: an initial phase to determine safe dosage levels and a second phase to further evaluate the treatment's effectiveness. The goal is to find new therapies that can improve survival and quality of life for patients with these challenging cancers.

Description

This study is testing a new combination of treatments for patients with recurrent or metastatic solid tumors. The treatment involves using E7777, a drug that targets specific immune cells, along with pembrolizumab, an immunotherapy drug. Immunotherapy has shown promise in treating some cancers, but its effectiveness varies. This study aims to see if combining these two drugs can improve outcomes for patients with difficult-to-treat cancers.

The trial has two parts: a dose escalation phase to find the safest dose, and a dose expansion phase to test the treatment in more patients. The study will include patients with various types of solid tumors, such as ovarian cancer and cancers with specific genetic markers. Participants will receive the treatment until their disease progresses or they experience unacceptable side effects. The study will use a method to carefully monitor and adjust doses to ensure safety and effectiveness.

E7777 has been used in other types of cancer and works by targeting immune cells that can suppress the body's ability to fight cancer. Pembrolizumab is an approved immunotherapy that helps the immune system attack cancer cells. By combining these treatments, researchers hope to enhance the body's natural defenses against cancer and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Ability to follow the study protocol.
  • Diagnosed with certain types of solid tumors that have not responded to standard treatments.
  • For the first phase, patients with advanced or recurrent tumors where pembrolizumab is approved.
  • For the second phase, patients with platinum-resistant ovarian cancer or specific genetic markers.
  • Must have measurable disease and provide a tumor sample for research.
  • Good overall health with a performance status of 0-1.
  • Life expectancy of at least 6 months.
  • Adequate blood and organ function based on specific lab tests.
  • HIV-positive patients are eligible if stable on treatment.
  • No known hepatitis infection.
  • Women of childbearing potential must use effective contraception during and after treatment.
  • Men must use condoms or abstain from intercourse during and after treatment.

Exclusion Criteria

  • History of certain brain or nervous system diseases unless stable and treated.
  • Uncontrolled pain or fluid buildup in the body.
  • Active or history of autoimmune diseases, with some exceptions.
  • History of lung diseases or active lung issues.
  • Active tuberculosis or significant heart disease.
  • Recent major surgery or other cancers within the past 3 years, with some exceptions.
  • Severe infections or recent antibiotic treatment.
  • Prior organ transplants.
  • Recent treatment with certain vaccines or investigational drugs.
  • Known allergies to study drugs or their components.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or after the study.

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