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Protein-based Therapy
pharmacological study for Solid Tumors
Phase 1
Waitlist Available
Led By Anthony El-Khoueiry
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This study is evaluating whether a drug called sEphB4-HSA can shrink tumors in people.
Eligible Conditions
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or inevaluable (IE)
Survival
Time to failure
+1 moreSide effects data
From 2020 Phase 1 & 2 trial • 88 Patients • NCT0201229682%
Fatigue
45%
Hot flashes
42%
Anorexia
39%
Constipation
27%
Pain
27%
Generalized muscle weakness
21%
Back pain
18%
Diarrhea
18%
Headache
18%
Hypertension
18%
Dizziness
18%
Nausea
15%
Weight loss
15%
Arthralgia
15%
Upper respiratory infection
12%
Abdominal pain
12%
Memory impairment
12%
Peripheral sensory neuropathy
12%
Hematuria
12%
Vomiting
12%
Fall
12%
Pain in extremity
12%
Urinary frequency
9%
Dyspnea
9%
Pelvic pain
9%
Hyperglycemia
9%
General disorders and administration site conditions - Other
9%
Anxiety
9%
Edema limbs
6%
White blood cell decreased
6%
Breast pain
6%
Alopecia
6%
Ear pain
6%
Flank pain
6%
Urinary incontinence
6%
Renal and urinary disorders - Other
6%
Investigations - Other
6%
Cystitis noninfective
6%
Fracture
6%
Hypokalemia
6%
Weight gain
6%
Watering eyes
6%
Paresthesia
6%
Neoplasms benign, malignant and unspecified
6%
Flu like symptoms
6%
Arthritis
6%
Bone pain
6%
Cough
6%
Urinary retention
3%
Neutrophil count decreased
3%
Small intestinal obstruction
3%
Depression
3%
Dyspepsia
3%
Platelet count decreased
3%
Confusion
3%
Ileus
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin infection
3%
Non-cardiac chest pain
3%
Blurred vision
3%
Muscle weakness lower limb
3%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzalutamide, Mifepristone)
Treatment (Enzalutamide)
Not Randomized
Trial Design
3Treatment groups
Experimental Treatment
Group I: Weekly Treatment (sEphB4-HSA)Experimental Treatment3 Interventions
Patients receive recombinant albumin fusion protein sEphB4-HSA IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Every 3 Weeks Treatment (sEphB4-HSA)Experimental Treatment3 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Every 2 Weeks Treatment (sEphB4-HSA)Experimental Treatment3 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,186 Total Patients Enrolled
The V Foundation for Cancer ResearchOTHER
18 Previous Clinical Trials
1,166 Total Patients Enrolled
Vasgene Therapeutics, IncIndustry Sponsor
7 Previous Clinical Trials
204 Total Patients Enrolled
Frequently Asked Questions
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