En undersøgelse af LY4052031 hos deltagere med avanceret eller metastatisk urothelial cancer eller andre solide tumorer (NEXUS-01)
3. november 2026 opdateret af: Eli Lilly and Company
Et fase 1a/1b-studie af LY4052031, et antistof-lægemiddelkonjugat rettet mod nectin-4, hos deltagere med avanceret eller metastatisk urothelial carcinom eller andre solide tumorer
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.
Studieoversigt
Status
Rekruttering
Betingelser
- Livmoderhalskræft
- Kræft i bugspytkirtlen
- Spiserørskræft
- Livmoderhalskræft
- Prostatakræft
- Blærekræft
- Tredobbelt negativ brystkræft
- Avanceret solid tumor
- Metastatisk fast tumor
- Ikke-småcellet lungekræft
- Planocellulært karcinom i hoved og hals
- Nyrebækkenkræft
- Urinblære neoplasma
- Tilbagevendende solid tumor
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
460
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Undersøgelse Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
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Darlinghurst, Australien, 2010
- Rekruttering
- St Vincent's Hospital
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Nedlands, Australien, 6009
- Rekruttering
- Linear Clinical Research
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London, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital
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Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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California
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Duarte, California, Forenede Stater, 91010-0269
- Rekruttering
- City of Hope National Medical Center
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La Jolla, California, Forenede Stater, 92093
- Rekruttering
- University of California, San Diego (UCSD) - Moores Cancer Center
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Los Angeles, California, Forenede Stater, 90024
- Rekruttering
- UCLA Department of Medicine-Hematology/Oncology
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Sarah Cannon Research Institute at HealthOne
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Florida
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St. Petersburg, Florida, Forenede Stater, 33705
- Afsluttet
- Florida Cancer Specialists and Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- University of Chicago Hospital
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Ikke rekrutterer endnu
- IU Simon Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Massachusetts General Hospital
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49546
- Rekruttering
- START Midwest Cancer and Hematology Centers of W Michigan
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine in St. Louis
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New York
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10029-6574
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
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New York, New York, Forenede Stater, 10032-3729
- Rekruttering
- Columbia University Irving Medical Center
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New York, New York, Forenede Stater, 10016
- Ikke rekrutterer endnu
- NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Sarah Cannon Research Institute
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Nashville, Tennessee, Forenede Stater, 37203
- Ikke rekrutterer endnu
- Tennessee Oncology PLLC
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Texas
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Houston, Texas, Forenede Stater, 77030-4000
- Rekruttering
- University of Texas MD Anderson Cancer Center
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- South Texas Accelerated Research Therapeutics (START)
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- University of Utah - Huntsman Cancer Institute
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West Valley City, Utah, Forenede Stater, 84119
- Rekruttering
- START Mountain Region
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Villejuif, Frankrig, 94805
- Rekruttering
- Institut Gustave Roussy (Igr)
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Chūōku, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital
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Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
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Kōtō City, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
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Nagoya, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center Hospital
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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer hospital
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Guangzhou, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
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Shanghai, Kina, 200000
- Rekruttering
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Barcelona, Spanien, 8908
- Rekruttering
- Catalan Institute of Oncology Duran i Reynals Hospital
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28050
- Rekruttering
- Hospital Madrid Norte Sanchinarro
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Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen Del Rocio
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Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
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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:
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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
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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.
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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.
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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
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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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
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: LY4052031 (Dose-escalation, Cohort A1)
Escalating doses of LY4052031 administered intravenously (IV). |
Intravenous |
|
Eksperimentel: LY4052031 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV. |
Intravenous |
|
Eksperimentel: LY4052031 (Dose-expansion, Cohort B1, B2, C1)
LY4052031 administered IV. |
Intravenous |
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Eksperimentel: LY4052031+ Pembrolizumab (Dose-expansion, Cohort D)
LY4052031 administered IV. Pembrolizumab administered IV. |
Intravenous Intravenous |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
Tidsramme: Cycle 1 (21 Days)
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Number of participants with dose-limiting toxicities (DLTs) |
Cycle 1 (21 Days)
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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
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
Tidsramme: Cycle 1 (21 Days)
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PK: Cmin of LY4052031 |
Cycle 1 (21 Days)
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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)
|
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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
|
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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
|
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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
|
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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
|
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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
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DCR per investigator assessed RECIST 1.1 |
Up to Approximately 48 Months or 4 Years
|
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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
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OS per investigator assessed RECIST 1.1 |
Up to Approximately 48 Months or 4 Years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- 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
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
1. juli 2024
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. maj 2027
Datoer for studieregistrering
Først indsendt
13. juni 2024
Først indsendt, der opfyldte QC-kriterier
13. juni 2024
Først opslået (Faktiske)
18. juni 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i det endokrine system
- Patologiske processer
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Lungesygdomme
- Neoplasmer i endokrine kirtler
- Neoplasmer i hoved og hals
- Pancreassygdomme
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Neoplastiske processer
- Esophageale sygdomme
- Lungeneoplasmer
- Ovariesygdomme
- Adnexale sygdomme
- Genitale neoplasmer, kvindelige
- Gonadale lidelser
- Hudsygdomme
- Brystsygdomme
- Ureterale sygdomme
- Karcinom
- Livmoderhalssygdomme
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Uterine neoplasmer
- Urinblæresygdomme
- Karcinom, pladecelle
- Brystneoplasmer
- Patologiske tilstande, tegn og symptomer
- Hud- og bindevævssygdomme
- Planocellulært karcinom i hoved og hals
- Prostatiske neoplasmer
- Esophageale neoplasmer
- Ovariale neoplasmer
- Ureterale neoplasmer
- Neoplasma Metastase
- Bugspytkirtel neoplasmer
- Karcinom, ikke-småcellet lunge
- Uterine cervikale neoplasmer
- Urinblære neoplasmer
- Tredobbelt negative brystneoplasmer
- Urologiske neoplasmer
- pembrolizumab
Andre undersøgelses-id-numre
- 18882
- LOXO-LNC-24001 (Anden identifikator: Eli Lilly and Company)
- J5I-OX-JZYA (Anden identifikator: Eli Lilly and Company)
- 2024-512927-36-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
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