BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy
Public ClinicalTrials.gov record NCT07869836. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the study is to evaluate the efficacy and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.
Study identification
- NCT ID
- NCT07869836
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 520 participants
Conditions and interventions
Conditions
- Urothelial Cancer
- Metastatic Urothelial Cancer
- Bladder Cancer
- Bladder Cancer (BC)
- Bladder (Urothelial, Transitional Cell) Cancer
- Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
- Bladder Ca
- Bladder Cancer Recurrent
- Bladder Cancer Stage IV
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
- Urothelial Carcinoma of the Urinary Bladder
Interventions
- T-Bren, Dose level 1 Drug
- T-bren, Dose level 2 Drug
- Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2026 (Estimated)
- Primary completion
- Dec 2028 (Estimated)
- Completion
- Dec 2029 (Estimated)
- Last update posted
- Oct 13, 2026
2026 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Georgia Cancer Center | Macon | Georgia | 31210 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07869836, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 13, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07869836 live on ClinicalTrials.gov.