Actively Recruiting
A Modular, Open Label, Randomized Phase II/III Trial to Assess Efficacy of Combining sEphB4-HSA (EphrinB2 Inhibitor) With Immunotherapy Regimens in Patients With EphrinB2-High Solid Tumors
Led by Vasgene Therapeutics, Inc · Updated on 2025-04-03
700
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with solid tumors that show high levels of EphrinB2 to evaluate the effects of adding the EphrinB2 inhibitor sEphB4-HSA to treatment regimens. The study aims to demonstrate whether combining sEphB4-HSA with immunotherapy improves treatment outcomes compared to standard care, focusing on safety and key cancer-related results in different patient groups. This is a modular, open-label, randomized trial involving patients with muscle-invasive bladder carcinoma (MIBC) and metastatic urothelial carcinoma (mUC) that express EphrinB2. Participants are assigned to different groups based on their cancer type and treatment eligibility. One group receives sEphB4-HSA combined with pembrolizumab, while the control group receives standard treatments such as gemcitabine-cisplatin or pembrolizumab alone for MIBC, or enfortumab vedotin plus pembrolizumab for mUC. sEphB4-HSA is given intravenously at 10 mg/kg on days 1 and 8 of each cycle, with treatment continuing until disease progression or unacceptable side effects. The trial includes up to four cycles of therapy, with dose modifications and scheduling managed by the treating physician. Participants will have regular assessments to monitor safety and treatment effects, including pathological response, overall survival, and radiographic response rates over up to five years. Laboratory tests and tumor profiling are required before enrollment, and performance status will be evaluated. The study also tracks disease-free and progression-free survival and records any toxicities related to the treatments. Follow-up visits and safety monitoring occur throughout the study to ensure participants are closely observed until study completion or withdrawal.
CONDITIONS
Brief 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 minimum of 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 assessed by USC Norris Core Lab.
- Zubrod performance status of 0 or 1.
- Women of childbearing potential must use contraception and have negative pregnancy test or meet specific reproductive criteria.
- Women must not be breastfeeding.
- Men sexually active with women of childbearing potential must agree to use two contraceptive methods.
- Adequate organ function based on lab tests within 14 days prior to randomization.
- For Module A: Urothelial carcinoma (excluding pure small cell), stage cT2 to cT4a N0M0, no systemic cancer therapy in previous 12 months, treatment choice declared before randomization.
- For Module B: Urothelial carcinoma (excluding pure small cell), Nectin4 non-amplified tumor, no systemic cancer therapy in previous 12 months, measurable disease by RECIST 1.1 criteria.
You will not qualify if you...
- Known symptomatic brain metastases requiring corticosteroids; stable treated brain metastases allowed.
- History of or active autoimmune disorders affecting the immune system.
- Known active bacterial, fungal, or viral infections including HBV, HCV, HIV/AIDS.
- Uncontrolled adrenal insufficiency.
- Active chronic liver disease.
- Concurrent or active second malignancy requiring systemic therapy.
- Medical conditions increasing risk or interfering with safety evaluation.
- Major surgery less than 6 weeks prior to first dose; minor surgery less than 4 weeks prior.
- History of severe hypersensitivity to monoclonal antibodies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 treatment cycles
Participants receive assigned treatment including sEphB4-HSA with Pembrolizumab, chemotherapy regimens, or control treatments according to their cohort and randomization. Treatment continues for up to 4 cycles or until disease progression or unacceptable toxicity.
Visits on days 1 and 8 of each cycle for sEphB4-HSA administration; other treatments follow standard schedules
Duration - Up to 60 months
Participants are monitored for safety and efficacy outcomes including survival and disease progression after treatment completion.
Periodic follow-up visits as determined by the study team
Trial Site Locations
Total: 1 location
1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
Research Team
J
Jon Cogan, MS
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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