NCT03993106

A Study of sEphB4-HSA in Kaposi Sarcoma

A Phase II Study of sEphB4-HSA in Kaposi Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Vasgene Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to learn if sEphB4-HSA will decrease the number or size of Kaposi sarcoma lesions in people.

Detailed description

sEphB4-HSA will be given through an intravenous infusion (into a vein). Each cycle of sEphB4-HSA will be 28 days (4 weeks). Each cycle of the study drug includes administration of 2 doses of sEphB4-HSA given on Days 1 and 15 of each cycle. Participants may continue on study protocol as long as their KS is continuing to respond or is clinically stable on study medication. Patients may come off treatment for the following reasons: * Disease progression. * Need for more than 2 dose reductions for toxicity. * Dose delay more than 28 days. * Patient withdraws consent. * Study termination by the Sponsor. * Participants who are noncompliant with respect to taking drugs, keeping appointments, or having tests required for the evaluation of drug safety and efficacy. * Participant's condition renders them unacceptable for further treatment in the judgment of the investigator.

Conditions

• Kaposi Sarcoma

Interventions

Type	Name	Description
DRUG	sEphB4-HSA	sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.

Timeline

• Start date: 2020-09-17
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2019-06-20
• Last updated: 2024-05-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study