sEphB4-HSA for Kaposi Sarcoma

No longer recruiting at 11 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: 5

Duration: Up to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, recombinant EphB4-HSA fusion protein, for individuals with Kaposi sarcoma, a cancer affecting the skin and sometimes other organs. The treatment aims to block blood vessels supplying the cancer and halt cancer cell growth. This trial may suit those with a biopsy-confirmed Kaposi sarcoma, visible skin lesions, and no improvement in their condition over the past month. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain treatments like full-dose anticoagulants or have had recent anti-neoplastic treatments. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have shown that patients treated with a protein called recombinant EphB4-HSA tolerate the treatment well. Research suggests that this protein might help stop cancer growth by cutting off the blood supply to tumors. Reports of severe side effects in these studies were rare, indicating that many people can handle the treatment without major issues. However, some individuals might experience different reactions. Overall, the available evidence suggests that the treatment is safe for most patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Kaposi sarcoma?

Most treatments for Kaposi Sarcoma, like chemotherapy and antiretroviral therapy, work by targeting rapidly dividing cells or managing the underlying HIV infection. But the recombinant EphB4-HSA fusion protein offers a novel approach by blocking the EphB4 receptor, which plays a role in tumor blood vessel growth. This protein is designed to disrupt the tumor's blood supply, potentially inhibiting its growth more directly. Researchers are excited because this targeted mechanism could lead to more effective and possibly less toxic treatments for patients with Kaposi Sarcoma.

What evidence suggests that this treatment might be an effective treatment for Kaposi Sarcoma?

Research has shown that a protein called recombinant EphB4-HSA, which participants in this trial will receive, might help treat Kaposi sarcoma. This protein may stop the growth of blood vessels that feed the cancer, potentially slowing or halting cancer cell growth. In earlier studies, about 24% of patients responded positively to this treatment, with their cancer shrinking or stopping its growth. This suggests that EphB4-HSA could be effective for some individuals with Kaposi sarcoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Ida Wong-Sefidan

Principal Investigator

AIDS Malignancy Consortium

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1 and 15. Patients with disease progression after 2 or more courses may receive treatment on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses.

Up to 12 months

2 visits per course, up to 4 visits per course if escalated

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Patients with partial response or better are followed up every 3 months for up to 1 year.

12 months

Every 3 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02799485

sEphB4-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.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02799485/sephb4-hsa-in-treating-patients-with-kaposi-sarcoma

sEphB4-HSA in Treating Patients With Kaposi Sarcoma This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating patients with Kaposi sarcoma. Recombinant EphB4-HSA ...

3. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5231?cancerType=sarcoma

sEphB4-HSA in Treating Patients with Kaposi Sarcoma sEphB4-HSA protein may block the growth of blood vessels that provide blood to the cancer, and may also prevent cancer cells from growing.

4. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT01642342/

Clinical Trial: NCT01642342 Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1. Courses repeat every 21 days in the absence of disease ...

5. synapse.patsnap.com synapse.patsnap.com/drug/c052f78a2e114eab80a3db097249ae72

sEphB4-HSA - Drug Targets, Indications, Patents RESULTS: Twenty-five patients were enrolled. Median follow up was 40.4 months (range 9.8 - 40.4). There were 6 responders (ORR 24%). There were 5 responders in ...

6. datamed.org datamed.org/search?datamed_dataset_index_entities%5Bquery%5D=EPHB4

ClinicalTrials.gov - DataMed Data Discovery Index 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 ...