Trial Outcomes & Findings for sEphB4-HSA in Treating Patients With Kaposi Sarcoma (NCT NCT02799485)

Results Overview

The observed proportions of participants experiencing clinical response will be calculated with 95% confidence intervals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 12 months (end of follow-up)

Results posted on

2026-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Overall Study STARTED	23
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	3
Overall Study Adverse events	3
Overall Study Disease progression	3
Overall Study Enrolled onto other study	1
Overall Study Relapse substance use	1
Overall Study Ineligibility	1

Baseline Characteristics

sEphB4-HSA in Treating Patients With Kaposi Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=23 Participants 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Age, Continuous	45.4 years old n=24 Participants
Sex: Female, Male Female	0 Participants n=24 Participants
Sex: Female, Male Male	23 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	4 Participants n=24 Participants
Race (NIH/OMB) White	15 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=24 Participants
Region of Enrollment United States	23 participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 12 months (end of follow-up)

The observed proportions of participants experiencing clinical response will be calculated with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=23 Participants 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Proportion of Participants Experiencing Clinical Response	56.5 percentage of participants Interval 34.9 to 76.1

SECONDARY outcome

Timeframe: Up to 12 months (end of follow-up)

The number of participants with adverse events will be reported.

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=23 Participants 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Safety of sEphB4-HSA Death	1 Participants
Safety of sEphB4-HSA Serious adverse events	5 Participants
Safety of sEphB4-HSA Adverse events	17 Participants

SECONDARY outcome

Timeframe: Up to Cycle 12 of treatment

Descriptive statistics and graphical displays will be used to evaluate correlation between response and trough levels of sEphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Cycle 12 of treatment

Descriptive statistics and graphical displays will be used to evaluate correlation between response and pharmacodynamics of sEphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in viral replication of HHV-8 will be investigated using the nonparametric Wilcoxon rank sum test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Cycle 12 of treatment

Descriptive statistics and graphical displays will be used to evaluate correlation between response and pharmacodynamics of sEphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in gene expression will be investigated using the nonparametric Wilcoxon rank sum test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Cycle 12 of treatment

Descriptive statistics and graphical displays will be used to evaluate correlation between response and pharmacodynamics of sEphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in immune cell counts will be investigated using the nonparametric Wilcoxon rank sum test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to12 months (Post-treatment evaluation)

Population: Baseline measurements of two participants were not collected.

Five measures of overall quality of life will be scored: physical well-being (0-40), emotional well-being (0-40), functional and global well-being (0-52), social well-being (0-32), and cognitive functioning (0-12). The total score is the sum of the five subdomains and ranges from 0 to 176. For KS-specific symptoms, responses may be dichotomized to reflect their positive or negative impact. General estimating equations using a log-binomial model will be used to assess changes in these symptoms over time. For all subdomains and total scores, higher scores indicate better health-related quality of life (HRQoL).

Outcome measures

Outcome measures
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=23 Participants 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Overall Quality of Life, Assessed Using the KS Functional Assessment of HIV Questionnaire Day1 of Cycle 4	139.87 scores on a scale Standard Error 8.42
Overall Quality of Life, Assessed Using the KS Functional Assessment of HIV Questionnaire 12 months (Post-treatment evaluation)	148.35 scores on a scale Standard Error 8.57
Overall Quality of Life, Assessed Using the KS Functional Assessment of HIV Questionnaire Baseline	136.32 scores on a scale Standard Error 8.42

Adverse Events

Treatment (Recombinant EphB4-HSA Fusion Protein)

Serious events: 5 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=23 participants at risk 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Cardiac disorders Chest pain	4.3% 1/23 • Number of events 1 • 12 months (Post-treatment evalution)
Cardiac disorders Palpitations	4.3% 1/23 • Number of events 1 • 12 months (Post-treatment evalution)
Infections and infestations Infections and Infestations-Other	4.3% 1/23 • Number of events 1 • 12 months (Post-treatment evalution)
Infections and infestations Lung infection	4.3% 1/23 • Number of events 1 • 12 months (Post-treatment evalution)
Infections and infestations Sepsis	4.3% 1/23 • Number of events 1 • 12 months (Post-treatment evalution)
Infections and infestations Skin inffection	13.0% 3/23 • Number of events 3 • 12 months (Post-treatment evalution)
Nervous system disorders Dizziness	4.3% 1/23 • Number of events 1 • 12 months (Post-treatment evalution)

Other adverse events

Other adverse events
Measure	Treatment (Recombinant EphB4-HSA Fusion Protein) n=23 participants at risk 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. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Quality-of-Life Assessment: Ancillary studies Recombinant EphB4-HSA Fusion Protein: Given IV
Gastrointestinal disorders Diarrhea	8.7% 2/23 • Number of events 3 • 12 months (Post-treatment evalution)
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2 • 12 months (Post-treatment evalution)
General disorders Chills	8.7% 2/23 • Number of events 2 • 12 months (Post-treatment evalution)
General disorders Fatigue	26.1% 6/23 • Number of events 7 • 12 months (Post-treatment evalution)
Investigations Neutrophil count decreased	13.0% 3/23 • Number of events 7 • 12 months (Post-treatment evalution)
Investigations White blood cell decreased	8.7% 2/23 • Number of events 4 • 12 months (Post-treatment evalution)
Musculoskeletal and connective tissue disorders Muscle cramp	8.7% 2/23 • Number of events 2 • 12 months (Post-treatment evalution)
Nervous system disorders Dizziness	17.4% 4/23 • Number of events 4 • 12 months (Post-treatment evalution)
Nervous system disorders Headache	30.4% 7/23 • Number of events 13 • 12 months (Post-treatment evalution)
Renal and urinary disorders Proteinuria	26.1% 6/23 • Number of events 10 • 12 months (Post-treatment evalution)
Vascular disorders Hypertension	78.3% 18/23 • Number of events 62 • 12 months (Post-treatment evalution)

Additional Information

Deukwoo Kwon

Statistical and Data Analysis Center, Consortium for Advancing Management and Prevention of Cancer in People with HIV

Phone: 501 526-6724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place