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Chemotherapy

Recombinant EphB4-HSA Fusion Protein for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Anthony El-Khoueiry
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a new protein drug when given with standard chemotherapy drugs to treat patients with solid tumors that have spread and can't be cured or controlled with treatment.

Eligible Conditions
  • Pancreatic Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Gallbladder Cancer
  • Non-Small Cell Lung Cancer
  • Cholangiocarcinoma
  • Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of overall response or SD
Incidence of toxicities, graded according to Common Terminology Criteria for Adverse Events version 4
Objective response using RECIST version 1.1
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (sEphB4-HSA, cisplatin, gemcitabine hydrochloride)Experimental Treatment5 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and 15 (beginning course 2), cisplatin IV over 120 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (sEphB4-HSA, docetaxel)Experimental Treatment4 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and 15 (beginning course 2) and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (sEphB4-HSA, nab-paclitaxel, gemcitabine hydrochloride)Experimental Treatment5 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22 (beginning course 2), paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Albumin human
FDA approved
Docetaxel
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
915 Previous Clinical Trials
1,603,663 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,253 Total Patients Enrolled
Vasgene Therapeutics, IncIndustry Sponsor
7 Previous Clinical Trials
245 Total Patients Enrolled
~6 spots leftby Jun 2025
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