NCT07869836 · SystImmune Inc.
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 is about
The objective of the study is to evaluate the effectiveness and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.
View original scientific description
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.
Interventions
DRUG
T-Bren, Dose level 1
T-bren: Administered intravenously on day 1 of each 21-day cycle
DRUG
T-bren, Dose level 2
TBren administered intravenously on day 1 of each 21-day cycle
DRUG
Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)
Gemcitabine administered intravenously on Day 1 and Day 8 of each 21-day cycle and Cisplatin or Carboplatin administered intravenously on Day 1 of each 21-day cycle
Primary outcome measures
Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) per RECIST v1.1 in the primary population
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether 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
Where
- Macon, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations