Brief Title: 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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Progression-Free Survival (PFS)

Primary Outcome 1 - Timeframe: Approximately 5 years

CONDITION

• Urothelial Cancer
• Metastatic Urothelial Cancer
• Bladder Cancer
• Bladder Cancer (BC)
• Bladder (Urothelial
• Transitional Cell) Cancer
• Bladder (Urothelial
• Transitional Cell) Cancer Metastatic or Unresectable
• Bladder Ca
• Bladder Cancer Recurrent
• Bladder Cancer Stage IV
• Urothelial Carcinoma Bladder
• Urothelial Carcinoma Recurrent
• Urothelial Carcinoma of the Urinary Bladder

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jimmy Liu Zhao, MD, PhD

Role: Study Director

Affiliation: SystImmune Inc.

Overall Contact

Name: Christine LaRock

Phone: 425-453-6841

Email: [email protected]

LOCATION