BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global Phase 3 study is randomized and open-label, comparing T-bren to investigator’s choice platinum-based chemotherapy in adults with HER2-expressing metastatic urothelial cancer after progression on anti-PD-(L)1 therapy. Participants will receive either T-bren at two dose levels or Gemcitabine plus a platinum agent (cisplatin or carboplatin). The trial will assess how well T-bren works and whether it has acceptable safety in this setting, using RECIST v1.1 to measure tumor response. Eligible patients must have measurable disease, adequate organ function, and HER2 expression confirmed by central testing. Exclusion criteria include prior topoisomerase inhibitor–ADC exposure and active CNS metastases.

Why it matters

Who can join: the full rules

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

Where it's running

• Central Georgia Cancer Center
  Macon, Georgia, United States Recruiting
• Central Georgia Cancer Center
  Macon, Georgia, United States Recruiting

Study contacts

• Study coordinator: Christine LaRock
• Email: Christine.LaRock@systimmune.com
• Phone: 425-453-6841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.