Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Først i human undersøgelse af CDR404 i HLA-A*02:01 Deltagere med MAGE-A4, der udtrykker solide tumorer

21. september 2026 opdateret af: CDR-Life AG

Fase 1, første-i-menneske-undersøgelse for at vurdere sikkerheden, tolerabiliteten og antitumoraktiviteten af ​​CDR404 i HLA-A*02:01-deltagere med MAGE-A4-udtrykkende solide tumorer

CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A*02:01 tissue marker and whose cancer is positive for MAGE-A4.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The CDR404-001 Phase 1 study will enrol patients with locally advanced, unresectable or metastatic tumors expressing MAGE-A4, which include advanced solid tumors, and will be conducted in multiple phases:

  1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
  2. To assess preliminary evidence of anti-tumor activity of CDR404
  3. To characterise the pharmacokinetics of CDR404
  4. To characterise the immunogenicity of CDR404
  5. To assess translational biomarkers

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Belgien
      • Antwerp, Belgien, 2650
        • Rekruttering
        • Universitair Ziekenhuis Antwerpen
        • Ledende efterforsker:
          • Hans Prenen, MD
        • Kontakt:
      • Brussels, Belgien, 1070
        • Rekruttering
        • Institut Jules Bordet
        • Ledende efterforsker:
          • Nuria Kotecki, MD
        • Kontakt:
      • Brussels, Belgien, 1200
        • Rekruttering
        • Cliniques Universitaires Saint-Luc, UCL Ouvain
        • Kontakt:
        • Ledende efterforsker:
          • Jean-Pascal Machiels, MD
      • Ghent, Belgien, 9000
        • Rekruttering
        • Universitair Ziekenhuis Gent
        • Ledende efterforsker:
          • Sylvie Rottey, MD
        • Kontakt:
  • Danmark
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige
        • Rekruttering
        • The Beatson West of Scotland Cancer Center
        • Ledende efterforsker:
          • Jeff Evans
        • Kontakt:
      • London, Det Forenede Kongerige
        • Ikke rekrutterer endnu
        • Guys and St Thomas' NHS Foundation Trust
        • Ledende efterforsker:
          • Rebecca Kristeleit
        • Kontakt:
    • London
      • Sutton, London, Det Forenede Kongerige, SM2 5PT
        • Rekruttering
        • Royal Marsden Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Alec MD Paschalis
  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Trukket tilbage
        • University of Miami
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Trukket tilbage
        • University of Michigan
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • Rekruttering
        • Providence Cancer Institute
        • Ledende efterforsker:
          • Rom Leidner, MD
        • Kontakt:
        • Kontakt:
          • Telefonnummer: +1-503-215-5763
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19106
        • Rekruttering
        • Pennsylvania Hospital
        • Ledende efterforsker:
          • Mark Diamond, MD
        • Kontakt:
  • Italien
      • Milan, Italien, 20141
        • Rekruttering
        • Isituto Europeo di Oncologia (IEO)
        • Kontakt:
        • Ledende efterforsker:
          • Guiseppe Curigliano, MD
      • Milan, Italien, 20089
  • Spanien
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Kontakt:
        • Ledende efterforsker:
          • Alberto Hernando Calvo, MD
      • Barcelona, Spanien, 08908
        • Rekruttering
        • Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
        • Kontakt:
        • Ledende efterforsker:
          • Ramon Salazar MD Martin, MD
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hospital 12 de Octubre
        • Kontakt:
        • Kontakt:
          • Sandra de la Llave, Marta Gutierrez, Elisa Lorente, Lidia Silvo, Veronica Silva
        • Ledende efterforsker:
          • Guillermo de Velasco, MD
      • Madrid, Spanien, 28050
      • Valencia, Spanien, 46026
        • Rekruttering
        • Hospital Universitari i Politecnic La Fe
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Guillermo Suay Montagud, MD
      • Valencia, Spanien, 46026
        • Rekruttering
        • Instituto de Investigacion Sanitaria (INCLIVA)
        • Kontakt:
        • Kontakt:
          • Inma Blasco
        • Ledende efterforsker:
          • Desamparados Roda Perez, MD

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:

  1. Provision of written informed consent
  2. HLA-A*02:01 positive
  3. MAGE-A4 positive tumor
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
  5. Selected advanced solid tumors
  6. Relapsed from, refractory to, or intolerant of standard therapy
  7. Measurable disease per RECIST v1.1
  8. Adequate organ function
  9. If applicable, must agree to use highly effective contraception

Exclusion Criteria:

  1. Symptomatic or untreated central nervous system metastasis
  2. Inadequate washout from prior anticancer therapy
  3. Significant ongoing toxicity from prior anticancer treatment
  4. Recent surgery
  5. Clinically significant cardiac disease
  6. Active infection requiring systemic antibiotic treatment
  7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
  8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
  9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
  10. Significant secondary malignancy
  11. History of chronic or recurrent active autoimmune disease requiring treatment
  12. Uncontrolled intercurrent illness
  13. Pregnancy or lactation.

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: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CDR404

Dose escalation
Biologisk: CDR404

IV infusions

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Presence of dose limiting toxicities (DLTs)
Tidsramme: From first dose to DLT period (21 days)

per Protocol
From first dose to DLT period (21 days)
Incidence and severity of (serious) adverse events ([S]AEs)
Tidsramme: From first dose to 90 days after the last dose

AEs, SAEs
From first dose to 90 days after the last dose
Anti-tumor response: Overall Response Rate (ORR)
Tidsramme: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

per RECIST 1.1
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease control rate (DCR)
Tidsramme: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

per RECIST 1.1
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Duration of response (DOR)
Tidsramme: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

per RECIST 1.1
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Progression-free Survival (PFS)
Tidsramme: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

per RECIST 1.1
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Overall Survival (OS)
Tidsramme: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

per RECIST 1.1
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Maximum serum concentration of CDR404 (Cmax)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Time to maximum serum concentration of CDR404 (Tmax)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Trough serum concentration of CDR404 (Ctrough)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Half-life of CDR404 (t1/2)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Area under the CDR404 serum concentration over time curve (AUC0-T)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

to the end of the dosing interval following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Volume of CDR404 distribution (Vd)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Average serum concentration of CDR404 (Cavg)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Serum drug levels of CDR404 at steady state (CL)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Accumulation ratio of CDR404 (Rac)
Tidsramme: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

following single and multiple dose administration
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Immunogenicity
Tidsramme: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Incidence of detectable anti-CDR404 antibodies (ADAs)
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Samarbejdspartnere og efterforskere

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

Sponsor

CDR-Life AG

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 (Faktiske)

24. maj 2024

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

25. april 2024

Først indsendt, der opfyldte QC-kriterier

2. maj 2024

Først opslået (Faktiske)

7. maj 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CDR404-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner