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En studie av LY4052031 hos deltakere med avansert eller metastatisk urotelkreft eller andre solide svulster (NEXUS-01)

20. oktober 2026 oppdatert av: Eli Lilly and Company

En fase 1a/1b-studie av LY4052031, et antistoff-medikamentkonjugat rettet mot nectin-4, hos deltakere med avansert eller metastatisk urothelial karsinom eller andre solide svulster

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 as monotherapy or in combination with pembrolizumab at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history.

Studietype

Intervensjonell

Registrering (Antatt)

460

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Telefonnummer: 1-317-615-4559
  • E-post: LillyTrials@Lilly.com

Studer Kontakt Backup

Studiesteder

  • Australia
      • Darlinghurst, Australia, 2010
        • Rekruttering
        • St Vincent's Hospital
      • Nedlands, Australia, 6009
        • Rekruttering
        • Linear Clinical Research
  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010-0269
        • Rekruttering
        • City of Hope National Medical Center
      • La Jolla, California, Forente stater, 92093
        • Rekruttering
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • Los Angeles, California, Forente stater, 90024
        • Rekruttering
        • UCLA Department of Medicine-Hematology/Oncology
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Rekruttering
        • Sarah Cannon Research Institute at HealthOne
    • Florida
      • St. Petersburg, Florida, Forente stater, 33705
        • Fullført
        • Florida Cancer Specialists and Research Institute
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Rekruttering
        • Emory University
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • Rekruttering
        • University of Chicago Hospital
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Har ikke rekruttert ennå
        • IU Simon Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Massachusetts General Hospital
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49546
        • Rekruttering
        • START Midwest Cancer and Hematology Centers of W Michigan
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University School of Medicine in St. Louis
    • New York
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forente stater, 10029-6574
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forente stater, 10016
        • Rekruttering
        • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
      • New York, New York, Forente stater, 10032-3729
        • Rekruttering
        • Columbia University Irving Medical Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Rekruttering
        • University Hospitals Cleveland Medical Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, Forente stater, 37203
        • Har ikke rekruttert ennå
        • Tennessee Oncology PLLC
    • Texas
      • Houston, Texas, Forente stater, 77030-4000
        • Rekruttering
        • University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • South Texas Accelerated Research Therapeutics (START)
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Rekruttering
        • University of Utah - Huntsman Cancer Institute
      • West Valley City, Utah, Forente stater, 84119
        • Rekruttering
        • START Mountain Region
  • Frankrike
      • Villejuif, Frankrike, 94805
        • Rekruttering
        • Institut Gustave Roussy (Igr)
  • Japan
      • Chūōku, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
      • Kashiwa, Chiba, Japan, 277-8577
        • Rekruttering
        • National Cancer Center Hospital East
      • Kōtō City, Japan, 135-8550
        • Rekruttering
        • The Cancer Institute Hospital of JFCR
      • Nagoya, Japan, 464-8681
        • Rekruttering
        • Aichi Cancer Center Hospital
  • Kina
      • Beijing, Kina, 100142
        • Rekruttering
        • Beijing Cancer hospital
      • Guangzhou, Kina, 510060
        • Rekruttering
        • Sun Yat-sen University Cancer Center
      • Shanghai, Kina, 200000
        • Rekruttering
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Spania
      • Barcelona, Spania, 8908
        • Rekruttering
        • Catalan Institute of Oncology Duran i Reynals Hospital
      • Madrid, Spania, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28050
        • Rekruttering
        • Hospital Madrid Norte Sanchinarro
      • Seville, Spania, 41013
        • Rekruttering
        • Hospital Universitario Virgen Del Rocio
  • Storbritannia
      • London, Storbritannia, EC1A 7BE
        • Rekruttering
        • St Bartholomew's Hospital
      • Manchester, Storbritannia, M20 4BX
        • Rekruttering
        • The Christie NHS Foundation Trust
  • Sør -Korea
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center

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:

  • Have one of the following solid tumor cancers:

    • Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
    • Cohort A2/B/D: urothelial carcinoma
    • Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer

  • Prior Systemic Therapy Criteria:

    • Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
    • Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
    • Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer.

  • Prior enfortumab vedotin specific requirements:

    • Cohorts A1/A2/C/D: prior treatment with enfortumab vedotin is allowed, but not required
    • Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
    • Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.

  • Measurability of disease

    • Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
    • Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria:

  • Individual with known or suspected uncontrolled CNS metastases
  • Individual with uncontrolled hypercalcemia
  • Individual with uncontrolled diabetes
  • Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Recent thromboembolic event and/or clinically significant bleeding disorder
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  • History of pneumonitis/interstitial lung disease
  • History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: LY4052031 (Dose-escalation, Cohort A1)

Escalating doses of LY4052031 administered intravenously (IV).
Legemiddel: LY4052031

Intravenous
Eksperimentell: LY4052031 (Dose-optimization, Cohort A2)

Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
Legemiddel: LY4052031

Intravenous
Eksperimentell: LY4052031 (Dose-expansion, Cohort B1, B2, C1)

LY4052031 administered IV.
Legemiddel: LY4052031

Intravenous
Eksperimentell: LY4052031+ Pembrolizumab (Dose-expansion, Cohort D)

LY4052031 administered IV. Pembrolizumab administered IV.
Legemiddel: LY4052031

Intravenous

Legemiddel: Pembrolizumab

Intravenous

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
Tidsramme: Cycle 1 (21 Days)

Number of participants with dose-limiting toxicities (DLTs)
Cycle 1 (21 Days)
Phase 1b: To assess the antitumor activity of LY4052031 as monotherapy or in combination with pembrolizumab: Overall response rate (ORR)
Tidsramme: Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to Approximately 48 Months or 4 Years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
Tidsramme: Cycle 1 (21 Days)

PK: Cmin of LY4052031
Cycle 1 (21 Days)
To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)
Tidsramme: Cycle 1 (21 Days)

PK: AUC of LY4052031
Cycle 1 (21 Days)
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Overall response rate (ORR)
Tidsramme: Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1))
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Duration of response (DOR)
Tidsramme: Up to Approximately 48 Months or 4 Years

DOR per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Time to response (TTR)
Tidsramme: Up to Approximately 48 Months or 4 Years

TTR per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Progression free survival (PFS)
Tidsramme: Up to Approximately 48 Months or 4 Years

PFS per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Disease control rate (DCR)
Tidsramme: Up to Approximately 48 Months or 4 Years

DCR per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Overall survival (OS)
Tidsramme: Up to Approximately 48 Months or 4 Years

OS per investigator assessed RECIST 1.1
Up to Approximately 48 Months or 4 Years

Samarbeidspartnere og etterforskere

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

Sponsor

Eli Lilly and Company

Etterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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)

1. juli 2024

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

13. juni 2024

Først innsendt som oppfylte QC-kriteriene

13. juni 2024

Først lagt ut (Faktiske)

18. juni 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 18882
  • LOXO-LNC-24001 (Annen identifikator: Eli Lilly and Company)
  • J5I-OX-JZYA (Annen identifikator: Eli Lilly and Company)
  • 2024-512927-36-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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. .

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