Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

BladderUrothelialADCT-brenHER2MetastaticSecond lineThird lineTargeted TherapyAntibody drug conjugate

Outcome Measures

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
Approximately 5 years

Secondary Outcomes (9)

Overall Survival (OS)
Approximately 5 years
Progression-Free Survival (PFS) in the ITT population
Approximately 5 years

Study Arms (3)

Arm A, T-bren Dose Level 1

EXPERIMENTAL

T-bren administered intravenously

Drug: T-Bren, Dose level 1

Arm B, T-bren Dose Level 2

EXPERIMENTAL

T-bren administered intravenously

Drug: T-bren, Dose level 2

Arm C, Control Arm, Platinum-based Chemotherapy (PBC)

ACTIVE COMPARATOR

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

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

Interventions

T-Bren, Dose level 1Drug

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

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

Arm A, T-bren Dose Level 1

T-bren, Dose level 2Drug

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

Also known as:

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

SystImmune Inc.
Industrylead

Study Sites (2)

Central Georgia Cancer Center

Macon, Georgia, 31210, United States

RECRUITING

Central Georgia Cancer Center

Macon, Georgia, 31210, United States

RECRUITING

Mackenzie Sanders, Study CoordinatorsCONTACT478-743-7068 mackenzie.sanders@aoncology.com

Rachel Warfield, Study CoordinatorsCONTACT478-743-7068 rachel.warfield@aoncology.com

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNeoplasmsNeoplasm Metastasis

Interventions

GemcitabinePlatinum CompoundsCisplatinCarboplatin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder Diseases

Study Officials

Jimmy Liu Zhao, MD, PhD
SystImmune Inc.
STUDY DIRECTOR

Central Study Contacts

Christine LaRock

CONTACT

425-453-6841 Christine.LaRock@systimmune.com

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 13, 2026

Study Start

September 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2028

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

Arm A, T-bren Dose Level 1

Arm B, T-bren Dose Level 2

Arm C, Control Arm, Platinum-based Chemotherapy (PBC)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

Arm A, T-bren Dose Level 1

Arm B, T-bren Dose Level 2

Arm C, Control Arm, Platinum-based Chemotherapy (PBC)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations