Is NCT06493552 recruiting in Santa Monica, CA?

Yes, NCT06493552 is currently recruiting participants at its Santa Monica, CA location. This muscle-invasive bladder carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Santa Monica clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Muscle-Invasive Bladder Carcinoma Clinical Trial in Santa Monica, CA

Q: How do I join the muscle-invasive bladder carcinoma clinical trial in Santa Monica?

To join this clinical trial in Santa Monica, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Muscle-Invasive Bladder Carcinoma Study in Santa Monica

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.

Sponsor: Vasgene Therapeutics, Inc

Who Can Participate

Inclusion Criteria

General Inclusion Criteria 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 effective methods for a period of 120 days after the last dose of treatment.

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 Inclusion Criteria

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. Module B inclusion Criteria

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 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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Santa Monica?

Yes, this clinical trial (NCT06493552) has an active research site in Santa Monica, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Muscle-Invasive Bladder Carcinoma Treatment Options in Santa Monica, CA

If you're searching for muscle-invasive bladder carcinoma treatment options in Santa Monica, CA, this clinical trial (NCT06493552) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Santa Monica research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced muscle-invasive bladder carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all muscle-invasive bladder carcinoma clinical trials near you to find additional studies recruiting in your area.

Muscle-Invasive Bladder Carcinoma Clinical Trial in Santa Monica, CA

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