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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

9. november 2026 opdateret af: SystImmune Inc.

A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

520

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Georgia
      • Macon, Georgia, Forenede Stater, 31210
        • Rekruttering
        • Central Georgia Cancer Center
        • Ledende efterforsker:
          • Bradley Sumrall, MD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A, T-bren Dose Level 1

T-bren administered intravenously
Medicin: T-Bren, Dose level 1

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

Andre navne:
  • T-Bren
  • BL-M07D1
  • Trastuzumab Brengitecan
Eksperimentel: Arm B, T-bren Dose Level 2

T-bren administered intravenously
Medicin: T-bren, Dose level 2

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

Andre navne:
  • T-Bren
  • BL-M07D1
  • Trastuzumab Brengitecan
Aktiv komparator: Arm C, Control Arm, Platinum-based Chemotherapy (PBC)
  1. Gemcitabine Administered intravenously
  2. Cisplatin or Carboplatin Administered intravenously
Medicin: Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Approximately 5 years

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) per RECIST v1.1 in the primary population
Approximately 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Approximately 5 years

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

Progression-Free Survival (PFS) by BICR per RECIST v1.1 in the ITT (Intent-to-Treat) Population
Approximately 5 years
Overall Survival (OS) in the ITT population
Tidsramme: Approximately 5 years
Approximately 5 years
Progression-Free Survival (PFS) by Investigator Assessment
Tidsramme: Approximately 5 years

Progression-Free Survival (PFS) by Investigator Assessment per RECIST v1.1
Approximately 5 years
Objective Response Rate (ORR) per RECIST v1.1
Tidsramme: Approximately 5 years
Approximately 5 years
Disease Control Rate (DCR) per RECIST v1.1
Tidsramme: Approximately 5 years
Approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Tidsramme: Approximately 5 years
Approximately 5 years
Time to Response (TTR) per RECIST v1.1
Tidsramme: Approximately 5 years
Approximately 5 years
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Approximately 5 years
Approximately 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SystImmune Inc.

Efterforskere

  • Studieleder: Jimmy Liu Zhao, MD, PhD, SystImmune Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

6. oktober 2026

Først indsendt, der opfyldte QC-kriterier

6. oktober 2026

Først opslået (Faktiske)

13. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BL-M07D1-UC-301

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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