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RecruitingNCT07869836Updated Oct 13, 2026

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

A Phase 3 interventional study of T-Bren, Dose level 1 and T-bren, Dose level 2 in Urothelial Cancer, Metastatic Urothelial Cancer and Bladder Cancer, sponsored by SystImmune Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by SystImmune Inc. (part of Sichuan Biokin Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study is a Global Phase 3, randomized, open-label, multicenter study of T-bren for the treatment of metastatic UC. This study will assess the efficacy and safety of T-bren versus PBC in adult participants with HER2-expressing UC after progression on anti-PD-(L)1-based therapy.

02

Conditions studied

  • 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

Keywords

  • Bladder
  • Urothelial
  • ADC
  • T-bren
  • HER2
  • Metastatic
  • Second line
  • Third line
  • Targeted Therapy
  • Antibody drug conjugate
03

In context

Urinary Bladder Neoplasms

1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.

This study's planned enrollment of 520 is above the median of 60 across 1,183 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

SystImmune Inc. is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Browse SystImmune Inc. studies →All Sichuan Biokin Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
520 participants (estimated)

Study arms

  • Experimental
    Arm A, T-bren Dose Level 1

    T-bren administered intravenously

    Drug: T-Bren, Dose level 1

  • Experimental
    Arm B, T-bren Dose Level 2

    T-bren administered intravenously

    Drug: T-bren, Dose level 2

  • Active comparator
    Arm C, Control Arm, Platinum-based Chemotherapy (PBC)

    1. Gemcitabine Administered intravenously 2. Cisplatin or Carboplatin Administered intravenously

    Drug: Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

Interventions

  • DrugT-Bren, Dose level 1

    T-bren: Administered intravenously on day 1 of each 21-day cycle

    Also known as: T-Bren, BL-M07D1, Trastuzumab Brengitecan

  • DrugT-bren, Dose level 2

    TBren administered intravenously on day 1 of each 21-day cycle

    Also known as: T-Bren, BL-M07D1, Trastuzumab Brengitecan

  • DrugGemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

    Drug page: Gemcitabine

    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

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) per RECIST v1.1 in the primary population

    Time frame: Approximately 5 years

Secondary outcomes

  1. Overall Survival (OS)

    Overall Survival (OS) in primary population

    Time frame: Approximately 5 years

  2. Progression-Free Survival (PFS) in the ITT population

    Progression-Free Survival (PFS) by BICR per RECIST v1.1 in the ITT (Intent-to-Treat) Population

    Time frame: Approximately 5 years

  3. Overall Survival (OS) in the ITT population

    Time frame: Approximately 5 years

  4. Progression-Free Survival (PFS) by Investigator Assessment

    Progression-Free Survival (PFS) by Investigator Assessment per RECIST v1.1

    Time frame: Approximately 5 years

  5. Objective Response Rate (ORR) per RECIST v1.1

    Time frame: Approximately 5 years

  6. Disease Control Rate (DCR) per RECIST v1.1

    Time frame: Approximately 5 years

  7. Duration of Response (DOR) per RECIST v1.1

    Time frame: Approximately 5 years

  8. Time to Response (TTR) per RECIST v1.1

    Time frame: Approximately 5 years

  9. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Approximately 5 years

07

Study locations

2 of 2 sites recruiting
  • Central Georgia Cancer Center
    Macon, Georgia 31210, United States
    Recruiting
  • Central Georgia Cancer Center
    Macon, Georgia 31210, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869836
Lead sponsor
SystImmune Inc.
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Oct 13, 2026

Study contacts

Christine LaRock
Contact
Christine.LaRock@systimmune.com
425-453-6841
Jimmy Liu Zhao, MD, PhD
study director · SystImmune Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Anti-HER2 Antibody-drug Conjugate BL-M07D1

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