Authorised Phase II and Phase III (Integrated) Metastatic urothelial cancer

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

EU CTIS ID: 2025-522400-24-00

What this study is testing

Phase 2: To determine the recommended dose of iza-bren to be used in Phase 3 of the trial. Phase 3: To evaluate the efficacy endpoints of iza-bren compared to Platinum based chemotherapy (PBC). Efficacy endpoints are measurements that look at how well the study treatment works.

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • People with a metastatic urothelial cancer, confirmed by looking at tissue or cell samples, whose disease has worsened on or after an immunotherapy-based treatment.
  • To be eligible for this trial, patients must have not been treated previously with more than two types of systemic cancer treatment.
  • To be part of this study, the patient's cancer must have grown or come back after being treated with a type of medicine (also known as anti-PD-(L)1 therapy) that helps the body's immune system fight cancer. It could have been used alone or with other treatments, but patients must have had at least one other treatment in addition to the anti-PD-(L)1 therapy. However, if the patient only had this therapy for a type of bladder cancer that has not spread to other parts of the body, they can't be part of this study.
  • Also, if the patient had anti-PD-(L)1 therapy as part of their surgery preparation or recovery, they may be eligible to participate if certain other conditions are met.
  • The study also involves a treatment called PBC, which uses drugs called cisplatin or carboplatin. So, patients need to be able to take these drugs.

You likely can't join if

  • If patients have had a treatment with PBC before, they need to have stopped taking them for at least a year to be part of this study.
  • Patients who did not respond well to previous PBC treatments, meaning their cancer did not shrink or were stable for less than 6 months, can't join this study.

The study team makes the final eligibility decision.

Where it's taking place

  • Israel
  • Australia
  • China
  • Brazil
  • United States
  • Korea, Republic of
  • Argentina
  • Japan
  • Canada
  • United Kingdom
  • Switzerland

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Israel; Australia; China; Brazil; United States; Korea, Republic of and 5 more location(s). 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 EU CTIS; the study team decides eligibility.