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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 3

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

520 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Prior topoisomerase inhibitor-based ADC therapy.
• Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis.
• Bladder cancers with small cell histology.
• 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.
• Active autoimmune diseases and inflammatory diseases.
• 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.
• Known human immunodeficiency virus infection.
• Active hepatitis B virus (HBV) infection.
• Active hepatitis C virus (HCV) infection.
• Active or latent tuberculosis.
• Other protocol-specified inclusion/ exclusion criteria apply

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

SystImmune Inc.

Study start

2026-11 Estimated

Primary completion

2028-12 Estimated

Study completion

2029-12 Estimated

First posted

Oct 13, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts