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Protein-based Therapy

sEphB4-HSA for Kaposi's Sarcoma

Phase 2
Recruiting
Led By Carl Millner, M.D.
Research Sponsored by Vasgene Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to enrollment and again within 24 hours prior to starting Cycle 1 of sEphB4-HSA. Further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME during receipt of sEphB4-HSA, and 12 weeks after discontinuation of sEphB4-HSA. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
Participants taking part in the optional biopsies must have cutaneous lesion(s) amenable to two (2) 5-mm tumor biopsy at study entry and optional second biopsy on therapy at week 8-12. Patients must have at least five additional lesions measurable for assessment with no improvement over the past month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks until study completion (average 6 months).
Awards & highlights

Study Summary

This trialstudies if sEphB4-HSA can reduce the growth of Kaposi sarcoma by blocking tumor cell growth and stopping blood vessels from supplying nutrients.

Who is the study for?
Adults with biopsy-proven Kaposi Sarcoma (skin or visceral) can join this trial. They must be over 18, have a life expectancy of more than 3 months, and be able to follow the study plan. People with HIV are eligible if they've been on stable antiretroviral therapy for at least 12 weeks. Women who can get pregnant and men must use birth control during the study.Check my eligibility
What is being tested?
The trial is testing sEphB4-HSA, which may stop tumor cells from growing by blocking substances that help tumors get nutrients through blood vessels. The goal is to see if it reduces the number or size of Kaposi sarcoma lesions.See study design
What are the potential side effects?
Potential side effects aren't specified here but based on similar treatments, one might expect issues like injection site reactions, fatigue, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am committed to using two forms of birth control and agree to regular pregnancy tests if I can become pregnant.
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I have skin lesions suitable for biopsy and at least five others that haven't improved in a month.
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My kidney function, measured by creatinine or its clearance, is within the normal range.
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I can take care of myself but might not be able to do active work.
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I have Kaposi's sarcoma confirmed by a skin biopsy.
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I am HIV positive and have been on a stable HIV treatment for at least 12 weeks.
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I have tried or cannot tolerate certain cancer treatments.
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I am 18 years old or older.
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My Kaposi Sarcoma hasn't improved in the last 3 months, but it has gotten worse in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks until study completion (average 6 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks until study completion (average 6 months). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS.
Secondary outcome measures
Changes in the VEGF-Notch-EphrinB2 angiogenic pathway
Cmax levels of recombinant sEphB4-HSA fusion protein
Effects of sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study DrugExperimental Treatment1 Intervention
All study participants will receive sEphB4-HSA through a needle in a vein in their arm for an hour in an outpatient clinic. All study participants will receive two doses of study drug on Days 1 and 15 of each 4 week cycle.

Find a Location

Who is running the clinical trial?

Vasgene Therapeutics, IncLead Sponsor
7 Previous Clinical Trials
241 Total Patients Enrolled
Carl Millner, M.D.Principal InvestigatorAIDS Healthcare Foundation

Media Library

sEphB4-HSA (Protein-based Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03993106 — Phase 2
Kaposi's Sarcoma Research Study Groups: Study Drug
Kaposi's Sarcoma Clinical Trial 2023: sEphB4-HSA Highlights & Side Effects. Trial Name: NCT03993106 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are partaking in this clinical experiment?

"Indeed, clinicaltrials.gov data indicates that this medical trial is open for enrollment. It was initially posted on September 17th 2020 and updated lastly on October 11th 2022. 65 participants need to be sourced from 3 distinct locales."

Answered by AI

What are the potential hazards associated with sEphB4-HSA?

"Our experts at Power gave sEphB4-HSA a score of 2 on the safety scale, as this is an exploratory Phase 2 trial with some evidence in terms of security but none for efficacy."

Answered by AI

What makes this clinical trial unique compared to other similar experiments?

"Since 2015, sEphB4-HSA has been the object of scientific inquiry. After Vasgene Therapeutics' initial trial in 2015 with 61 participants, this agent was granted Phase 1 drug approval. There are presently seven active research projects for sEphB4-HSA spanning over 20 cities and one country."

Answered by AI

Is there an existing corpus of research encompassing sEphB4-HSA?

"sEphB4-HSA initially received attention in 2015 at Hoag Memorial Hospital Presbyterian. As of yet, no trials have reached completion; however, 7 studies are actively recruiting with several located within the city limits of Dallas, Texas."

Answered by AI

Is enrollment for this study open at the moment?

"Affirmative. The clinicaltrials.gov portal reveals that this trial, which was first published on September 17th 2020, is continuing to search for participants. 65 individuals need to be selected from 3 separate medical centres."

Answered by AI
~10 spots leftby Dec 2024