Phase 2
N=23
sEphB4-HSA in Treating Patients With Kaposi Sarcoma
Skin Kaposi Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT02799485 ↗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
| Outcome | Result | p-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
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.