Study on sEphB4-HSA Treatment for Solid Tumors with High EphrinB2 Levels

Sponsor: Vasgene Therapeutics, Inc

Sponsor score: 0

ClinicalTrials ID:NCT06493552

Provider View

This clinical trial is testing a new treatment called sEphB4-HSA for patients with solid tumors that have high levels of a protein called EphrinB2. The study aims to see if this treatment can improve outcomes and is safe for patients.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment, sEphB4-HSA, in patients with solid tumors that have high levels of EphrinB2. Researchers want to find out if this treatment can provide additional benefits and is safe to use. Patients will continue treatment until their disease progresses or they experience unacceptable side effects.

Description

This study is exploring whether blocking a protein called EphrinB2 can improve treatment results for patients with certain types of cancer. The treatment being tested is sEphB4-HSA, which is thought to work well with another drug called pembrolizumab to boost the immune system's ability to fight cancer.

In one part of the study, patients with a type of bladder cancer (MIBC) will receive either sEphB4-HSA with pembrolizumab or a standard chemotherapy treatment. If patients cannot or do not want to receive the standard chemotherapy, they may receive pembrolizumab alone.

Another part of the study will look at patients with a type of bladder cancer that has returned after treatment. These patients will receive sEphB4-HSA with pembrolizumab to see if this combination is more effective than other treatments.

Participants will be randomly assigned to receive either the new treatment or the standard treatment. They will be closely monitored for safety and effectiveness throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to provide informed consent.
  • Men and women aged 18 or older.
  • Must provide a sample from a previous biopsy or tissue sample.
  • Tumor must be tested for specific markers, including EphrinB2 and PD-L1.
  • Must have a performance status score of 1 or less, indicating good overall health.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test.
  • Men must agree to use two forms of contraception if sexually active with women of childbearing potential.
  • Must have adequate organ function based on specific blood tests.

Module A:

  • Must have a type of bladder cancer called urothelial carcinoma.
  • Cancer must be at a specific stage and not have been treated with systemic therapy in the past year.
  • Must declare treatment choice if assigned to the standard treatment group.

Module B:

  • Must have urothelial carcinoma with specific characteristics.
  • Must not have received systemic therapy in the past year.
  • Must have measurable disease based on specific criteria.

Exclusion Criteria

  • Patients with active brain metastases requiring steroids are not eligible. Patients with treated brain metastases may participate if they meet certain conditions.
  • Patients with autoimmune disorders or conditions affecting the immune system are not eligible.
  • Patients with active infections like hepatitis B, hepatitis C, or HIV are not eligible.
  • Patients with uncontrolled adrenal insufficiency or chronic liver disease are not eligible.
  • Patients with another active cancer requiring treatment are not eligible.
  • Patients with medical conditions that increase risk or interfere with the study are not eligible.
  • Patients who have had major surgery within 6 weeks or minor surgery within 4 weeks before starting the study are not eligible.
  • Patients with severe allergic reactions to monoclonal antibodies are not eligible.

Locations

FACILITYZIPCITYSTATE
Sarcoma Oncology Center90403Santa MonicaCalifornia

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