OncoMatch/Clinical Trials/NCT07869836
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
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
Is NCT07869836 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including T-Bren, Dose level 1 and T-bren, Dose level 2 for urothelial cancer.
Treatment: T-Bren, Dose level 1 · T-bren, Dose level 2 · Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression (testing required; no eligibility threshold specified)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy
Disease progression or recurrence during or following anti-PD-(L)1-based therapy
Cannot have received: topoisomerase inhibitor-based antibody-drug conjugate
Prior topoisomerase inhibitor-based ADC therapy
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Central Georgia Cancer Center · Macon, Georgia
- Central Georgia Cancer Center · Macon, Georgia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07869836 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase inhibitor-based antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages