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
| NCT ID | NCT07869836 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | SystImmune Inc. |
| Condition | Urothelial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 520 participants |
| Start Date | 2026-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 520 participants in total. It began in 2026-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Jimmy Liu Zhao, MD, PhD
STUDY DIRECTOR
SystImmune Inc.
Frequently Asked Questions
Who can join the NCT07869836 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07869836 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 520 participants.
Is NCT07869836 currently recruiting?
Yes, NCT07869836 is actively recruiting participants. Contact the research team at Christine.LaRock@systimmune.com for enrollment information.
Where is the NCT07869836 trial being conducted?
This trial is being conducted at Macon, United States, Macon, United States.
Who is sponsoring the NCT07869836 clinical trial?
NCT07869836 is sponsored by SystImmune Inc.. The principal investigator is Jimmy Liu Zhao, MD, PhD at SystImmune Inc.. The trial plans to enroll 520 participants.
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