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New treatment option for Muscle-Invasive Bladder Carcinoma
Official title Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
ClinicalTrials.gov ID: NCT06493552
What this study is testing
What is SEphB4-HSA?
SEphB4-HSA is an investigational medicine, being studied as a potential treatment for muscle-invasive bladder carcinoma.
Also referred to as sB4HSA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General for Both Arms
- 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...
You likely can't join if
- Patients with known symptomatic brain metastases requiring systemic corticosteroids. Patients with previously diagnosed brain metastases are eligible...
- History of or active autoimmune disorders (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus...
- Known active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or...
- Uncontrolled adrenal insufficiency.
- Any known active chronic liver disease.
- Concurrent or active second malignancy requiring systemic therapy is excluded.
See the full eligibility criteria
- General for Both Arms
- 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. o NOTE: Contraception should be continued using two highly...
- 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 Module A 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 assigned by chance 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- History of severe hypersensitivity reaction to any monoclonal antibody.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.