Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Først i menneskelig studie av CDR404 i HLA-A*02:01 Deltakere med MAGE-A4 som uttrykker solide svulster

21. september 2026 oppdatert av: CDR-Life AG

Fase 1, første-i-menneske-studie for å vurdere sikkerheten, toleransen og antitumoraktiviteten til CDR404 i HLA-A*02:01-deltakere med MAGE-A4-uttrykkende solide svulster

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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

Studietype

Intervensjonell

Registrering (Antatt)

42

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Antwerp, Belgia, 2650
        • Rekruttering
        • Universitair Ziekenhuis Antwerpen
        • Hovedetterforsker:
          • Hans Prenen, MD
        • Ta kontakt med:
      • Brussels, Belgia, 1070
        • Rekruttering
        • Institut Jules Bordet
        • Hovedetterforsker:
          • Nuria Kotecki, MD
        • Ta kontakt med:
      • Brussels, Belgia, 1200
        • Rekruttering
        • Cliniques Universitaires Saint-Luc, UCL Ouvain
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jean-Pascal Machiels, MD
      • Ghent, Belgia, 9000
        • Rekruttering
        • Universitair Ziekenhuis Gent
        • Hovedetterforsker:
          • Sylvie Rottey, MD
        • Ta kontakt med:
  • Danmark
      • Copenhagen, Danmark, DK-2100
  • Forente stater
    • Florida
      • Miami, Florida, Forente stater, 33136
        • Tilbaketrukket
        • University of Miami
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Tilbaketrukket
        • University of Michigan
    • Oregon
      • Portland, Oregon, Forente stater, 97213
        • Rekruttering
        • Providence Cancer Institute
        • Hovedetterforsker:
          • Rom Leidner, MD
        • Ta kontakt med:
        • Ta kontakt med:
          • Telefonnummer: +1-503-215-5763
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19106
        • Rekruttering
        • Pennsylvania Hospital
        • Hovedetterforsker:
          • Mark Diamond, MD
        • Ta kontakt med:
  • Italia
      • Milan, Italia, 20141
        • Rekruttering
        • Isituto Europeo di Oncologia (IEO)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Guiseppe Curigliano, MD
      • Milan, Italia, 20089
  • Spania
      • Barcelona, Spania, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alberto Hernando Calvo, MD
      • Barcelona, Spania, 08908
        • Rekruttering
        • Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ramon Salazar MD Martin, MD
      • Madrid, Spania, 28041
        • Rekruttering
        • Hospital 12 de Octubre
        • Ta kontakt med:
        • Ta kontakt med:
          • Sandra de la Llave, Marta Gutierrez, Elisa Lorente, Lidia Silvo, Veronica Silva
        • Hovedetterforsker:
          • Guillermo de Velasco, MD
      • Madrid, Spania, 28050
      • Valencia, Spania, 46026
        • Rekruttering
        • Hospital Universitari i Politecnic La Fe
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Guillermo Suay Montagud, MD
      • Valencia, Spania, 46026
        • Rekruttering
        • Instituto de Investigacion Sanitaria (INCLIVA)
        • Ta kontakt med:
        • Ta kontakt med:
          • Inma Blasco
        • Hovedetterforsker:
          • Desamparados Roda Perez, MD
  • Storbritannia
      • Glasgow, Storbritannia
        • Rekruttering
        • The Beatson West of Scotland Cancer Center
        • Hovedetterforsker:
          • Jeff Evans
        • Ta kontakt med:
      • London, Storbritannia
        • Har ikke rekruttert ennå
        • Guys and St Thomas' NHS Foundation Trust
        • Hovedetterforsker:
          • Rebecca Kristeleit
        • Ta kontakt med:
    • London
      • Sutton, London, Storbritannia, SM2 5PT
        • Rekruttering
        • Royal Marsden Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alec MD Paschalis

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CDR404

Dose escalation
Biologisk: CDR404

IV infusions

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CDR-Life AG

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. mai 2024

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

25. april 2024

Først innsendt som oppfylte QC-kriteriene

2. mai 2024

Først lagt ut (Faktiske)

7. mai 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CDR404-001

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere