700 Participants Needed

sEphB4-HSA for Bladder Cancer

JC
Overseen ByJon Cogan, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Vasgene Therapeutics, Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not have had systemic therapy for cancer in the previous 12 months.

How does the drug sEphB4-HSA work for bladder cancer?

sEphB4-HSA is unique because it targets the EphB4 receptor, which is overexpressed in bladder cancer cells, leading to tumor cell death and reduced blood vessel formation in tumors. This approach is different from traditional chemotherapy as it directly targets cancer cell survival mechanisms and has shown significant tumor regression in studies.12345

Who Is on the Research Team?

SS

Sarmad Sadeghi, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with thyroid, bladder, or urothelial cancer that's high in EphrinB2. They must provide biopsy tissue, not be breastfeeding, use contraception if applicable, and have a good performance status (able to carry out daily activities).

Inclusion Criteria

Women must not be breastfeeding
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
Willing and able to provide informed consent
See 9 more

Exclusion Criteria

History of severe hypersensitivity reaction to any monoclonal antibody
My adrenal glands are not working properly and it's not under control.
I have an ongoing liver disease.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sEphB4-HSA + Pembrolizumab or other regimens based on cohort assignment. Treatment continues until disease progression or unacceptable toxicities.

4 cycles
Visits on days 1 and 8 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment. Imaging assessments every 6 weeks for the first 3 months, then every 12 weeks.

Up to 60 months

Extension

Participants may continue to receive treatment if they benefit and tolerate it well, as per protocol.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • sEphB4-HSA
Trial Overview The study tests sEphB4-HSA combined with other drugs like Enfortumab vedotin and Pembrolizumab against solid tumors high in EphrinB2. It aims to see if adding sEphB4-HSA improves treatment outcomes compared to standard options.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: sEphB4-HSA + Pembrolizumab in Naive mUCExperimental Treatment2 Interventions
Group II: sEphB4-HSA + Pembrolizumab in MIBCExperimental Treatment2 Interventions
Group III: Enfortumab Vedotin (EV) + Pembrolizumab in Naive mUCActive Control2 Interventions
Group IV: Gemcitabine-Cisplatin (GC) or Pembrolizumab Alone in MIBCActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vasgene Therapeutics, Inc

Lead Sponsor

Trials
9
Recruited
1,000+

Citations

Targeted Inhibition of P4HB Promotes Cell Sensitivity to Gemcitabine in Urothelial Carcinoma of the Bladder. [2022]
Deciphering the immunological and prognostic features of bladder cancer through platinum-resistance-related genes analysis and identifying potential therapeutic target P4HB. [2023]
EphB4 receptor tyrosine kinase is expressed in bladder cancer and provides signals for cell survival. [2018]
B7-Homolog 4 Promotes Epithelial-Mesenchymal Transition and Invasion of Bladder Cancer Cells via Activation of Nuclear Factor-κB. [2022]
The differential expression of EphB2 and EphB4 receptor kinases in normal bladder and in transitional cell carcinoma of the bladder. [2022]
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