Actively Recruiting
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Led by Vasgene Therapeutics, Inc · Updated on 2025-04-03
700
Participants Needed
1
Research Sites
489 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA. The primary objective of this study is to demonstrate additive therapeutic benefit for sEphB4-HSA. The secondary objectives are to determine whether the sEphB4-HSA containing regimen is safe and whether the oncological endpoints of importance in each cohort improve as a result of treatment with sEphB4-HSA containing regimen relative to a predefined threshold or to a control arm in the cohort where available. Treatment continues until progression of disease or unacceptable toxicities arise.
CONDITIONS
Official Title
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Men and women 18 years of age or older
- Must provide cell block or at least 15 slides from diagnostic biopsy or archival tissue
- Tumor tissue must be submitted for molecular profiling including PD-L1 assay
- Tumor must express EphrinB2 as confirmed by USC Norris Core Lab
- Zubrod performance status of 0 or 1
- Women of childbearing potential must use contraception or meet defined criteria (hysterectomy, ovarian failure, postmenopausal status)
- Women must not be breastfeeding
- Men sexually active with women of childbearing potential must agree to use two effective contraceptive methods during and for 120 days after treatment
- Adequate organ function with specified laboratory values within 14 days prior to randomization
- For Cohort A: urothelial carcinoma (excluding pure small cell), clinical stage cT2 to cT4a N0M0, no systemic therapy in previous 12 months, and treatment choice declared if randomized to control
- For Cohort B: urothelial carcinoma (excluding pure small cell), tumor must be Nectin4 non-amplified, no systemic therapy in previous 12 months, and measurable disease by RECIST1.1 criteria
You will not qualify if you...
- Known symptomatic brain metastases requiring systemic corticosteroids
- History or active autoimmune disorders compromising immune system
- Known active infections including hepatitis B, hepatitis C, HIV/AIDS
- Uncontrolled adrenal insufficiency
- Known active chronic liver disease
- Concurrent or active second malignancy requiring systemic therapy
- Medical conditions increasing risk or interfering with safety assessments
- Major surgery less than 6 weeks prior to first dose
- Minor surgery less than 4 weeks prior to first dose
- History of severe hypersensitivity to any monoclonal antibody
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
Research Team
J
Jon Cogan, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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