Trial · NCT03993106
A Study of sEphB4-HSA in Kaposi Sarcoma
NCT03993106, Phase 2, Unknown, Vasgene Therapeutics, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of sEphB4-HSA in Kaposi Sarcoma. Trials, record NCT03993106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03993106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of sEphB4-HSA in Kaposi Sarcoma
- NCT number
- NCT03993106
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 65 participants, estimated
- Lead sponsor
- Vasgene Therapeutics, Inc
- Conditions
- Kaposi Sarcoma
- Interventions
- sEphB4-HSA
- First posted
- 2019-06-20
- Last updated
- 2024-05-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS. | Every 4 weeks until study completion (average 6 months). | The observed proportions of participants experiencing clinical response and unacceptable toxicity will be calculated with 95% confidence intervals. For clinical response, the Kaplan-Meier method will be used to estimate the distribution for time to death assessed for up to 1 month after treatment completion; for time to progression assessed from chemotherapy initiation to first documented progression up to 1 month after treatment completion; and for time to response assessed from the first dose until first documented response up to 1 month after completion of treatment. The Kaplan-Meier method will then be used to estimate the distribution of time to response, time to relapse, and time to death. Adverse events will be tabulated according to type and severity. |
| Secondary | Effects of sEphB4-HSA on tumor cell apoptosis and proliferation. | Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days). | Immunohistochemistry will be performed on biopsy samples and levels will be determine pre and post sEphB4-HSA. |
| Secondary | Effects of sEphB4-HSA on immune response as measured in blood | Blood draws at baseline, Cycle 1 Days 1 & 15 (one cycle is 28 days) and Day 1 of Cycles 4, 7, 10 and at study completion (average of 6 months) | Peripheral blood samples will be used for flow cytometric analysis, cytokine measurements, and in vitro studies of T cells. Biopsy samples will be used to perform cytokine assays and evaluate for tumor regression and immune infiltration. |
| Secondary | Effects of sEphB4-HSA on immune response as measured in tissue | Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days). | Biopsy samples will be used to perform cytokine assays and evaluate for tumor regression and immune infiltration. |
| Secondary | Effects of sEphB4-HSA on viral replication and gene expression of human herpes virus-8 (HHV-8). | Baseline, Cycle 1, Day 1, Day 1 of every third cycle (one cycle is 28 days) thereafter and at study completion (average of 6 months). | HHV-8 copy number in peripheral blood mononuclear cells (PBMC) and plasma will be assessed by real-time quantitative RT-PCR. The same assay will also investigate a set of known endothelial-specific mRNAs (targeted array). |
| Secondary | Changes in the VEGF-Notch-EphrinB2 angiogenic pathway | At study entry and week 8-12 of study drug. | Optional biopsies will be taken and immunohistochemistry will be performed to determine expression for genes in the VEGF-Notch-EphrinB2 pathway. |
| Secondary | Trough levels of recombinant sEphB4-HSA fusion protein | Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days) | Trough levels (lowest concentration of sEphB4-HSA in the participant's bloodstream). sEphB4-HSA levels will be measured from blood draws on which ELISA will be run. |
| Secondary | Cmax levels of recombinant sEphB4-HSA fusion protein | Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days) | Cmax levels (highest concentration of sEphB4-HSA in the participant's bloodstream). sEphB4-HSA levels will be measured from blood draws on which ELISA will be run. |
| Secondary | Quality of Life Questionnaire | Baseline, day 1 of study drug, day 1 of Cycle 4 (one cycle is 28 days), at study completion (average of 6 months) | Five measures of overall quality of life will be scored: physical well-being, emotional well-being, functional and global well-being, social well-being, and cognitive functioning. Changes in these measures will be assessed over time. |
| Secondary | Samples for banking | Optional skin biopsies at baseline, Cycle 1 Day 1 and any Day Cycle 3 (one cycle is 28 days). Blood draws at baseline, Cycle 1 Days 1 & 15 and Day 1 of Cycles 4, 7, 10 and at study completion (average of 6 months) | Archive peripheral blood mononuclear cells (PBMCs) and tissue samples to be used in conjunction with samples collected in subsequent trials of sEphB4-HSA for future studies including identification of biomarkers predictive of response |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03993106
GET https://conductscience.org/api/trials/v1/NCT03993106/registered