Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

En studie av LY4052031 hos deltagare med avancerad eller metastaserad urothelial cancer eller andra fasta tumörer (NEXUS-01)

3 november 2026 uppdaterad av: Eli Lilly and Company

En fas 1a/1b-studie av LY4052031, ett antikropps-läkemedelskonjugat som riktar sig mot nectin-4, hos deltagare med avancerad eller metastaserad uroteliala karcinom eller andra fasta tumörer

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

460

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: LY4052031 (Dose-escalation, Cohort A1)

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

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

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

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

LY4052031 administered IV.
Läkemedel: LY4052031

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

LY4052031 administered IV. Pembrolizumab administered IV.
Läkemedel: LY4052031

Intravenous

Läkemedel: Pembrolizumab

Intravenous

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Up to Approximately 48 Months or 4 Years

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eli Lilly and Company

Utredare

  • Studierektor: 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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2024

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

13 juni 2024

Först inskickad som uppfyllde QC-kriterierna

13 juni 2024

Första postat (Faktisk)

18 juni 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera