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Phase 2 N=23 Treatment

sEphB4-HSA in Treating Patients With Kaposi Sarcoma

Skin Kaposi Sarcoma

Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Jun 2026
Primary outcome: Primary: Proportion of Participants Experiencing Clinical Response — 56.5 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Quality-of-Life Assessment (Behavioral); Recombinant EphB4-HSA Fusion Protein (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
AIDS Malignancy Consortium
Primary completion
Feb 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Participants Experiencing Clinical Response
56.5
SECONDARY
Safety of sEphB4-HSA
1; 5; 17
SECONDARY
Trough Levels of Recombinant sEphB4-HSA Fusion Protein
SECONDARY
Viral Replication of HHV-8 of Recombinant sEphB4-HSA Fusion Protein
SECONDARY
Gene Expression of HHV-8 of Recombinant sEphB4-HSA Fusion Protein
SECONDARY
Immune Response and Modulation of Recombinant sEphB4-HSA Fusion Protein

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Participants may be treatment naïve, refractory to or intolerant of one or more prior therapies, or treated with prior systemic treatment including but not limited to liposomal doxorubicin
  • Participants must have biopsy-proven KS involving skin with or without visceral involvement
  • If HIV-positive, any cluster of differentiation (CD)4 count will be allowed on study
  • Eastern Cooperative Oncology Group (ECOG) performance status = = 60%
  • Life expectancy of greater than 3 months
  • Absolute neutrophil count >= 1,500/mcL*
  • Participants may be receiving growth factor support to meet these criteria
  • Platelets >= 100,000/mcL
  • Total bilirubin = = 60 mL/min/1.73 m^2 as calculated by Cockcroft-Gault formula for participants with creatinine levels above institutional normal
  • Participants must have cutaneous lesion(s) amenable to four (4) 5-mm tumor biopsies during the study (either 4 separate lesions measuring >= 5 mm each OR 2 separate lesions measuring >= 10 mm each) and at least five additional lesions measurable for assessment with no improvement over the past month
  • 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
  • A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Documentation of HIV status; if participant is HIV positive, HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection
  • If the participant is HIV negative, documentation of a negative result for any federally approved, licensed HIV rapid test within 4 weeks prior to study enrollment will suffice; if the initial rapid test is positive, further approved confirmatory test results must be present to document the subject's HIV status
  • If participant is HIV positive, participants must be on a stable antiretroviral regimen for at least 12 weeks prior to study enrollment
  • There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is evidence for progression of KS in the 4 weeks immediately prior to study enrollment
  • Participants must, in the opinion of the investigator, be capable of complying with the protocol

Exclusion Criteria

  • Inability to understand and inability to provide informed consent
  • Participants who are receiving any other investigational agents
  • Participants who have had anti-neoplastic treatment for KS (including chemotherapy, radiotherapy, local treatment including topical fluorouracil [5-FU], biological therapy or investigational therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study OR those who have not recovered fro
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02799485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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