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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

27 Jan 2026 → ongoing

Decision date (initial)

2025-12-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number

2025-522400-24-00

WHO UTN

U1111-1322-9071

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Efficacy, Dose response

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.

Secondary objectives 2

1. Phase 2: To evaluate the efficacy endpoints of 2 different doses of iza-bren, and to understand how iza-bren is processed by the body (pharmacokinetics).
2. Phase 3: To evaluate the efficacy of iza-bren versus PBC

Conditions and MedDRA coding

Metastatic urothelial cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. To be eligible for this trial, patients must have not been treated previously with more than two types of systemic cancer treatment.
3. 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.
4. 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.
5. 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.

Exclusion criteria 2

1. 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.
2. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data.
2. Phase 3: Efficacy will be evaluated by comparing progression-free survival (time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (how long a patient lives) between iza-bren and PBC.

Secondary endpoints 2

1. Phase 2 and 3: Additional efficacy endpoints will be tested in both groups of patients, including what proportion of participants respond to treatment (objective response rate), how long until participants respond to treatment (time to response), how long a participants’ response to treatment lasts (duration of response), time without cancer growing (progression free survival) and how long patients survive (overall survival).
2. In Phase 3 only, the time it takes for participants to report a decline in their quality of life will be measured and compared.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 6

Locations

11 EU/EEA countries · 66 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 100 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications