470 Participants Needed

Izalontamab Brengitecan for Bladder Cancer

Recruiting at 139 trial locations
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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?

This trial tests a new treatment, Izalontamab Brengitecan, for individuals with bladder cancer that has spread and worsened after previous treatment, specifically immunotherapy. The study compares this treatment to the usual platinum-based chemotherapy to determine which is more effective for this cancer type. Suitable candidates for this trial include those whose bladder cancer has returned or progressed within 12 months after previous treatments and have at least one measurable tumor. As a Phase 2/3 trial, it evaluates the treatment's effectiveness in a larger group and is one step away from potential FDA approval, offering participants a chance to advance cancer treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Izalontamab Brengitecan appears safe in studies. It achieved a 44.1% success rate in shrinking tumors and an 88.2% rate in controlling the disease in patients with advanced bladder cancer, indicating many patients responded well to the treatment.

In other studies, patients lived without disease progression for an average of 7.3 months, suggesting the treatment may slow the disease without causing serious side effects. These results indicate the treatment is generally well-tolerated, with no major safety issues reported so far.

Although the treatment remains under study, the evidence so far is encouraging for its safety in humans.12345

Why are researchers excited about this trial's treatments?

Izalontamab Brengitecan is unique because it represents a novel approach in the treatment of bladder cancer, potentially offering new hope for patients. Unlike traditional treatments such as chemotherapy and immunotherapy, Izalontamab Brengitecan combines an antibody-drug conjugate that specifically targets cancer cells, delivering a powerful anti-cancer agent directly to the tumor. This targeted mechanism of action minimizes damage to healthy cells, potentially reducing side effects compared to standard treatments. Researchers are excited about its ability to precisely attack bladder cancer cells, which could lead to more effective outcomes and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for metastatic urothelial cancer?

Research has shown that Izalontamab Brengitecan, which participants in this trial may receive, offers promising results for treating bladder cancer. In patients with advanced bladder cancer, nearly half experienced tumor shrinkage. The treatment also stabilized the disease for most patients, with 88.2% achieving disease control. Additionally, studies found that patients went an average of 7.3 months without disease progression, and 66.4% had no progression at 6 months. These findings suggest that Izalontamab Brengitecan could be a promising option for those whose cancer has worsened after standard immunotherapy.12345

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with advanced bladder cancer that has worsened after immunotherapy. They should be fairly active and healthy (ECOG 0-1), have not had platinum chemo in the last year, no more than two prior cancer treatments, and no untreated brain metastases or certain previous drug treatments.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
Participants must have ≥ 1 measurable lesion per RECIST v1.1
My cancer returned within a year after my last treatment.
See 3 more

Exclusion Criteria

I haven't had platinum-based chemotherapy in the last year.
I have not had ADC therapy targeting EGFR or HER3.
Other protocol-defined inclusion/exclusion criteria apply
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Izalontamab Brengitecan or platinum-based chemotherapy

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Izalontamab Brengitecan
Trial Overview The study compares Izalontamab Brengitecan (Iza-bren), a new therapy, against standard platinum-based chemotherapy drugs like Cisplatin or Carboplatin combined with Gemcitabine. It's to see which is better for patients whose bladder cancer has spread after initial immunotherapy.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm DExperimental Treatment1 Intervention
Group II: Arm BExperimental Treatment1 Intervention
Group III: Arm AExperimental Treatment1 Intervention
Group IV: Arm CActive Control3 Interventions
Group V: Arm EActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

Izalontamab Brengitecan Data Reinforce the Value of ...Izalontamab brengitecan showed a 44.1% objective response rate and 88.2% disease control rate in advanced urothelial carcinoma patients. The ...
Study Details | NCT07106762 | Phase 2/3 Trial of ...IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial ...
Phase II/III Study of Izalontamab Brengitecan vs. Platinum- ...Efficacy endpoints are measurements that examine how well the study treatment works. The study duration for each participant is approximately up ...
BL-B01D1 Shows Preliminary Efficacy, Favorable Safety in ...A median progression-free survival of 7.3 months was observed across the 2.2 mg/kg cohort, with a 6-month rate of 66.4%. Izalontamab brengitecan ...
Izalontamab Brengitecan Earns FDA Breakthrough ...In these trials, iza-bren demonstrated an encouraging safety profile and evidence of improved clinical outcomes in patients with EGFR-mutant ...
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