IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

New trial tests novel drug against standard chemo for advanced bladder cancer

NCT: NCT07106762 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Bristol-Myers Squibb · Started: 2025-09-30 · Est. Completion: 2033-11-18

Plain English Summary

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Urothelial Cancer. This trial tests a new drug called izalontamab brengitecan against standard chemotherapy for advanced bladder cancer. It is for patients with metastatic urothelial cancer whose disease has worsened after immunotherapy. Participants will be randomly assigned to receive either the new drug or standard chemotherapy. Standard chemotherapy options include platinum-based drugs like cisplatin or carboplatin, often given with gemcitabine. The trial aims to enroll 470 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have advanced urothelial cancer that has spread and has not responded to immunotherapy. You must be eligible to receive platinum-based chemotherapy and have at least one measurable tumor. You cannot join if you have had platinum-based chemotherapy in the last 12 months or more than two prior treatment regimens. Individuals with active, untreated brain metastases cannot participate. This trial is studying Urothelial Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The trial will measure how long patients live without their cancer getting worse (Progression-Free Survival) and how long they live overall (Overall Survival). The specific primary outcome measures are: Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 (Approximately 3 months); Phase 3: Progression-Free Survival (PFS) (Up to 5 years); Phase 3: Overall Survival (OS) (Up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for new treatments in patients with advanced bladder cancer that has stopped responding to immunotherapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Urothelial Cancer, where improved treatment options are needed.

Investor Insight

This trial is investigating a novel drug in a significant patient population, indicating a potential new option for a difficult-to-treat cancer. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for you, especially if your cancer has progressed after immunotherapy. Participation involves receiving either the new drug or standard chemotherapy, with regular check-ups and tests to monitor your health and cancer. You will be monitored for side effects and your cancer's response to treatment. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Participants must have histologically confirmed advanced urothelial carcinoma.
* Participants must be eligible to receive platinum-based chemotherapy.
* Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
* Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
* Participants must have ≥ 1 measurable lesion per RECIST v1.1.
* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Exclusion Criteria:

* Participants must not have platinum-based chemotherapy exposure within 12 months.
* Participants must not have received \>2 prior regimens irrespective of the setting.
* Participants must not have prior ADC therapy targeting EGFR or HER3.
* Participants must not have prior therapy with topoisomerase 1 inhibitor.
* Participants must not have active, untreated brain metastases.
* Other protocol-defined inclusion/exclusion criteria apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07106762?

NCT07106762 is a Phase 3 INTERVENTIONAL study titled "Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 470 participants.

What conditions does NCT07106762 study?

This trial investigates treatments for Urothelial Cancer. The primary condition under study is Urothelial Cancer.

What treatments are being tested in NCT07106762?

The interventions being studied include: Iza-bren (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Carboplatin (DRUG). Specified dose on specified days

What does Phase 3 mean for NCT07106762?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07106762?

This trial is currently "Recruiting." It started on 2025-09-30. The estimated completion date is 2033-11-18.

Who is sponsoring NCT07106762?

NCT07106762 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07106762?

The trial aims to enroll 470 participants. The trial is currently recruiting and accepting new participants.

How is NCT07106762 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07106762?

The primary outcome measures are: Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 (Approximately 3 months); Phase 3: Progression-Free Survival (PFS) (Up to 5 years); Phase 3: Overall Survival (OS) (Up to 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07106762 being conducted?

This trial is being conducted at 20 sites, including Gilbert, Arizona; Fullerton, California; Palo Alto, California; Sacramento, California and 16 more sites (United States).

Where can I find official information about NCT07106762?

The official record for NCT07106762 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07106762. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07106762 testing in simple terms?

This trial tests a new drug called izalontamab brengitecan against standard chemotherapy for advanced bladder cancer. It is for patients with metastatic urothelial cancer whose disease has worsened after immunotherapy.

Why is this trial significant?

This trial addresses a critical need for new treatments in patients with advanced bladder cancer that has stopped responding to immunotherapy. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07106762?

Potential side effects of izalontamab brengitecan are not fully detailed but may include those common to chemotherapy. Standard chemotherapy can cause side effects such as nausea, fatigue, hair loss, and a weakened immune system. The trial is open-label, meaning both you and your doctor will know which treatment you are receiving, which could introduce bias. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07106762?

Ask your doctor if this trial is a good fit for you, especially if your cancer has progressed after immunotherapy. Participation involves receiving either the new drug or standard chemotherapy, with regular check-ups and tests to monitor your health and cancer. You will be monitored for side effects and your cancer's response to treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07106762 signal from an investment perspective?

This trial is investigating a novel drug in a significant patient population, indicating a potential new option for a difficult-to-treat cancer. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive either the new drug or standard chemotherapy. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.