NCT07869836RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- Sept 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- SystImmune Inc.
- Diseases
- Bladder cancer
- NCT number
- NCT07869836
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 520
- From Sept 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior topoisomerase inhibitor-based ADC therapy.
- Other prior or concurrent malignancies except for certain localized cancers or low-grade prostate cancer (if approved by sponsor), or other malignancy treated with curative intent with a disease-free interval of at least 3 years.
- Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract within 6 months of randomization.
- History of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Advanced/clinically significant lung disease (eg, poorly controlled chronic obstructive pulmonary disease or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to randomization.
Other illness
- Bladder cancers with small cell histology.
- Active autoimmune diseases and inflammatory diseases.
- Known human immunodeficiency virus infection.
- Active hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV) infection.
- Active or latent tuberculosis.
Other
- Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis.
- Other protocol-specified inclusion/ exclusion criteria apply
Who the study is looking for
- Histologically or cytologically documented metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder, or urethra. Minor histologic variants (ie, \<50% overall) are acceptable, provided that TCC is the dominant histology.
- Disease progression or recurrence during or following anti-PD-(L)1-based therapy.
- Fresh biopsy or archival tumor samples.
- Documented HER2 expression by central laboratory testing.
- Eligible to receive carboplatin or cisplatin in combination with gemcitabine.
- At least 1 measurable lesion based on RECIST v1.1.
- An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adequate organ function.
- Adequate coagulation parameters.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Central Georgia Cancer Center Coordinator of this site? Confirm its status | Macon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.