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

Part of paid clinical trials in Macon, Georgia.

Sponsor
SystImmune Inc.
Study ID
NCT07869836
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • T-Bren, Dose level 1 — DRUG
    T-bren: Administered intravenously on day 1 of each 21-day cycle
  • T-bren, Dose level 2 — DRUG
    TBren administered intravenously on day 1 of each 21-day cycle
  • Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) — DRUG
    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

Study Details

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.

Key Dates

First listed
Oct 13, 2026
Start date
Sep 30, 2026
Status verified
Oct 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A, T-bren Dose Level 1
    T-bren administered intravenously
  • Experimental: Arm B, T-bren Dose Level 2
    T-bren administered intravenously
  • Active Comparator: Arm C, Control Arm, Platinum-based Chemotherapy (PBC)
    1. Gemcitabine Administered intravenously 2. Cisplatin or Carboplatin Administered intravenously

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Approximately 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Central Georgia Cancer CenterMaconGeorgia31210-
Central Georgia Cancer CenterMaconGeorgia31210
Mackenzie Sanders, Study Coordinators
[email protected]
478-743-7068
Rachel Warfield, Study Coordinators
[email protected]
478-743-7068
Bradley Sumrall, MD (PRINCIPAL_INVESTIGATOR)

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Bladder cancer
By specialty
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By research site
Central Georgia Cancer Center· Macon, GA

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