sEphB4-HSA for Kaposi Sarcoma

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AIDS Malignancy Consortium

Must be taking: Antiretrovirals

Must not be taking: Anticoagulants, Antiplatelets, Aspirin

Disqualifiers: Brain metastases, Uncontrolled hypertension, Recent major bleed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of blood vessels that provide blood to the cancer, and may also prevent cancer cells from growing.

Research Team

Ida Wong-Sefidan

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

This trial is for individuals with Kaposi Sarcoma, which may include those who haven't been treated before or those who didn't respond to or couldn't tolerate previous treatments. HIV-positive participants are welcome if they're on stable antiretroviral therapy. Participants need a life expectancy over 3 months and must have skin lesions suitable for biopsy. They should not be pregnant and must agree to use effective birth control methods.

Inclusion Criteria

You are expected to live for more than 3 months.

Participants must, in the opinion of the investigator, be capable of complying with the protocol

I have Kaposi's sarcoma confirmed by a biopsy, affecting my skin and possibly other organs.

Exclusion Criteria

Participants who are receiving any other investigational agents

I do not have severe diabetes, COPD requiring recent hospitalization, or conditions that make treatment risky for me.

I have not had a serious infection or been treated for one in the last 14 days.

Treatment Details

Interventions

• Recombinant EphB4-HSA Fusion Protein

Trial Overview The study is testing the effects of recombinant EphB4-HSA fusion protein on Kaposi Sarcoma. This treatment aims to block blood vessel growth that feeds cancer cells and prevent the cancer cells from growing further.

Participant Groups

Group I: Treatment (recombinant EphB4-HSA fusion protein) Experimental Treatment 4 Interventions

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1 and 15. Patients with disease progression after 2 or more courses who have not experienced toxicity may receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of further disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials

64

Recruited

9,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Vasgene Therapeutics, Inc

Industry Sponsor

Trials

9

Recruited

1,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+