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Study of sEphB4-HSA for Bladder Cancer

This study is looking at new ways to treat muscle-invasive bladder cancer (MIBC) and metastatic urothelial carcinoma (mUC), which are types of bladder cancer. It's testing a drug called sEphB4-HSA along with other treatments like pembrolizumab (an immunotherapy drug), gemcitabine, cisplatin (chemotherapy drugs), or enfortumab vedotin. The goal is to see if adding sEphB4-HSA can improve how well these treatments work, especially in tumors that have high levels of a specific marker called EphrinB2. Researchers want to know if this combination is safe and if it helps patients live longer or respond better to treatment. You might be able to join if you are 18 or older and have certain types of bladder cancer with high EphrinB2 levels.

Study design
This is an interventional study planning to enroll 700 participants. Patients with MIBC will be randomly assigned to receive either sEphB4-HSA plus pembrolizumab or standard chemotherapy.
What's involved
You will need to provide tissue samples from your tumor for molecular testing. Treatment continues until your disease progresses or you experience unacceptable side effects.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be tracked for up to 60 months (5 years) after starting treatment. Your response to treatment will also be assessed for up to 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06493552

Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors

Recruiting
PHASE2Ages 18+InterventionalTreatment
Vasgene Therapeutics, Inc
~700 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:SEphB4-HSAPembrolizumabGemcitabineCisplatinEnfortumab vedotin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improved pathological response (pCR) in sEphB4-HSA+Pembro vs. Standard of Care for MIBC
Measured over Through study completion, an average of 6 months
+3 more outcomes measured

Conditions

Muscle-Invasive Bladder Carcinoma
Metastatic Urothelial Carcinoma

Explore related trials

Metastatic Urothelial CarcinomaMuscle Invasive Bladder CarcinomaSolid NeoplasmEphrin-B2NECTIN4 Gene

NCT06493552

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sarcoma Oncology Center

    Santa Monica, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sarmad Sadeghi, MD · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Jon Cogan, MS
[email protected]
323-221-7818
Email the study team

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Eligibility criteria

Inclusion

Willing and able to provide informed consent.
Men and women 18 years of age, or older.
Must provide the cell block or a minimum of 15 slides from the diagnostic biopsy or archival tissue.
Tumor tissue must be submitted for molecular profile through a commercial service such as Tempus, CARIS, Foundation One, etc. This must include a PD-L1 assay.
Tumor must express EphrinB2 as assessed by USC Norris Core Lab.
Zubrod performance status of less than or equal to 1.
Women of childbearing potential must use method(s) of contraception. The individual methods of contraception should be determined in consultation with the treating physician or investigator.
Women of childbearing potential are eligible if serum pregnancy test obtained during screening is negative. Women are also eligible if one of the following criteria is met:
Have undergone a documented hysterectomy and/or bilateral oophorectomy; OR
Have medically confirmed ovarian failure; OR
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; OR
A serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women.
Women must not be breastfeeding.
Men who are sexually active with women of childbearing potential must agree to use 2 contraceptive methods with a failure rate of less than 1% per year.
Adequate organ function as defined below using baseline laboratory requirements obtained within 14 days prior to randomization:
Measured or calculated creatinine clearance (CrCl) greater than or equal to 30 mL/min using the Cockcroft-Gault formula using actual weight (NOT ideal or adjusted weights).
WBC ≥2000/uL
Neutrophils ≥1500/uL
Platelets ≥100x103/uL
Hemoglobin ≥9g/dL
AST ≤3 x ULN
ALT ≤3 x ULN
Bilirubin ≤1.5 x ULN
Urothelial carcinoma, variant components and differentiations allowed. Pure small cell not allowed.
cT2 to cT4a N0M0, by TURBT or imaging.
No systemic therapy for cancer in the previous 12 months.
Choice of treatment if randomized to the control arm must be declared prior to randomization. If cisplatin ineligible or refusing, pembrolizumab must be approved by patient's insurance prior to randomization.
Urothelial carcinoma, variant components and differentiations allowed. Pure small cell not allowed.
Tumor must be Nectin4 non-amplified- testing performed during pre-screening assessment.
No systemic therapy for cancer in the previous 12 months.
Measurable disease as defined by RECIST1.1 criteria

Exclusion

Patients with known symptomatic brain metastases requiring systemic corticosteroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable. Mild neurological deficit is allowed, if it does not interfere with the ability to judge the safety on the trial.
History of or active autoimmune disorders (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease) and other conditions that compromise or impair the immune system.
Known active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) -related illness. Routine testing is not required; however, treating physicians may use their discretion to determine whether testing is necessary.
Uncontrolled adrenal insufficiency.
Any known active chronic liver disease.
Concurrent or active second malignancy requiring systemic therapy is excluded.
Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
Major surgery less than 6 weeks prior to the first dose of study drug. Minor surgery less than 4 weeks prior to the first dose of study drug. Insertion of vascular access device ≥ 7 days prior to 1st dose of study drug is allowed.
History of severe hypersensitivity reaction to any monoclonal antibody.

What this trial measures

  • Improved pathological response (pCR) in sEphB4-HSA+Pembro vs. Standard of Care for MIBCThrough study completion, an average of 6 months

    Pathologic complete response (pCR), a binary outcome. pCR is defined as absence of the muscle invasive component of the tumor in the radical cystectomy specimen by pathologic review. CIS (pTis), pT1, and pTa are considered to be pCR. All patients with pCR must have pN0/M0. Patients don't have pCR due to refusal of radical cystectomy, dropout prior to radical cystectomry, or pathologic evaluation results are inconclusive or unknown will be classified as non-responders in the ITT.

  • Improved Overall Survival (OS) in sEphB4-HSA+Pembro vs. Standard of Care for MIBCFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

    Overall survival (OS) defined as period from randomization to death from any cause. OS will be censored at the last follow-up if patients are known to be alive. OS is a time to event variable of the primary interest.

  • Improved Radiographic Objective Response Rate (ORR) in sEphB4+Pembro vs. Control in mUCFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

    Using RECIST 1.1 on CT or MR imaging of chest, MR imaging of Chest, Abdomen and Pelvis every 6 weeks for the first 3 months and then every 12 weeks.

  • Non-inferior Overall Survival (OS) of sEphB4+Pembro vs. Control in mUCFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

    Overall survival (OS) defined as period from randomization to death from any cause. OS will be censored at the last follow-up if patients are known to be alive. OS is a time to event variable of the primary interest.