RecruitingPhase 2Phase 3NCT06493552

Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors

A Modular, Open Label, Randomized Phase II/III Trial to Assess Efficacy of Combining sEphB4-HSA (EphrinB2 Inhibitor) With Immunotherapy Regimens in Patients With EphrinB2-High Solid Tumors


Sponsor

Vasgene Therapeutics, Inc

Enrollment

700 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA. The primary objective of this study is to demonstrate additive therapeutic benefit for sEphB4-HSA. The secondary objectives are to determine whether the sEphB4-HSA containing regimen is safe and whether the oncological endpoints of importance in each cohort improve as a result of treatment with sEphB4-HSA containing regimen relative to a predefined threshold or to a control arm in the cohort where available. Treatment continues until progression of disease or unacceptable toxicities arise.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called sEphB4-HSA in people with solid tumors (cancers in organs or tissues) that have high levels of a protein called EphrinB2, which the drug targets to block tumor growth. **You may be eligible if...** - You are 18 or older and have an advanced solid tumor that has not responded to standard treatment - Your tumor has been tested and shows high levels of EphrinB2 - You are in reasonably good physical condition - You are able to provide tumor tissue for analysis **You may NOT be eligible if...** - Your tumor does not express EphrinB2 - You have not had your tumor molecularly profiled - You have uncontrolled or active brain metastases - You have serious ongoing infections, significant heart problems, or other conditions that would make participation unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSEphB4-HSA

A recombinant protein comprised of the soluble form of human receptor EphB4 fused to human serum albumin.

DRUGPembrolizumab

Antibody to human PD-1.

DRUGGemcitabine

A chemotherapy drug used to treat various types of cancer.

DRUGCisplatin

A type of chemotherapy drug called an alkylating agent used to treat various types of cancer.

DRUGEnfortumab vedotin

Nectin-4-directed antibody and microtubule inhibitor conjugate.


Locations(1)

Sarcoma Oncology Center

Santa Monica, California, United States

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NCT06493552


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