NCT07106762 Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
| NCT ID | NCT07106762 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Urothelial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 470 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2029-01-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 470 participants in total. It began in 2025-09-30 with a primary completion date of 2029-01-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07106762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07106762 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07106762 currently recruiting?
Yes, NCT07106762 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07106762 trial being conducted?
This trial is being conducted at Gilbert, United States, Fullerton, United States, Palo Alto, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT07106762 clinical trial?
NCT07106762 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 470 participants.
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