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

NCT06493552 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

  • Muscle-Invasive Bladder Carcinoma
  • Metastatic Urothelial Carcinoma

Interventions

DRUG

SEphB4-HSA

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

DRUG

Pembrolizumab

Antibody to human PD-1.

DRUG

Gemcitabine

A chemotherapy drug used to treat various types of cancer.

DRUG

Cisplatin

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

DRUG

Enfortumab vedotin

Nectin-4-directed antibody and microtubule inhibitor conjugate.

Sponsors & Collaborators

  • Vasgene Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Sarmad Sadeghi, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2029-09-30
Completion
2034-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06493552 on ClinicalTrials.gov