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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

ConditionsUrothelial CancerMetastatic Urothelial CancerBladder CancerBladder Cancer (BC)Bladder (Urothelial, Transitional Cell) CancerBladder (Urothelial, Transitional Cell) Cancer Metastatic or UnresectableBladder CaBladder Cancer RecurrentBladder Cancer Stage IVUrothelial Carcinoma BladderUrothelial Carcinoma RecurrentUrothelial Carcinoma of the Urinary Bladder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSystImmune Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

520 Participants
are divided into 3 treatment groups
Group A: Arm A, T-bren Dose Level 1Experimental treatment 1 intervention
Group B: Arm B, T-bren Dose Level 2Experimental treatment 1 intervention
Group C: Arm C, Control Arm, Platinum-based Chemotherapy (PBC)Active comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SystImmune Inc.

Lead sponsor

Source ClinicalTrials.gov
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