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sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

NCT04033432 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-04-27

Study results available
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Summary

The purpose of this phase II, single-arm, open-label, three center study is to evaluate the efficacy, safety, and tolerability of sEphB4-HSA in patients with mCRPC (metastatic castration-resistant prostate cancer). The study drug, sEphB4-HAS, is a form of protein that has not been approved for sale by the United States Food and Drug Administration (FDA). The study drug prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.

Conditions

  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents
  • Metastatic Prostate Adenocarcinoma
  • Progressive Disease
  • Prostate Carcinoma Metastatic in the Bone
  • Prostate Carcinoma Metastatic in the Soft Tissue
  • PSA Progression
  • Stage IVB Prostate Cancer AJCC v8
  • Testosterone Less Than 50 ng/dL

Interventions

BIOLOGICAL

Recombinant EphB4-HSA Fusion Protein

Given IV

Sponsors & Collaborators

  • Vasgene Therapeutics, Inc

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • Maha H Hussain, M.D. · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2021-02-05
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04033432 on ClinicalTrials.gov