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En undersøgelse af LY4170156 hos deltagere med udvalgte avancerede solide tumorer

3. november 2026 opdateret af: Eli Lilly and Company

Et første-i-menneskeligt, fase 1a/1b-forsøg for at vurdere sikkerheden, tolerabiliteten og den foreløbige effektivitet af LY4170156, et antistof-lægemiddelkonjugat rettet mod folatreceptor α-udtrykkende tumorceller, hos deltagere med udvalgte avancerede solide tumorer

The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

575

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

Studiesteder

  • Australien
      • Adelaide, Australien, 5000
        • Rekruttering
        • Cancer Research SA
        • Ledende efterforsker:
          • Meena Okera
      • QLD, Australien, 4101
        • Rekruttering
        • Icon Cancer Centre South Brisbane
        • Ledende efterforsker:
          • Jermaine Coward
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Rekruttering
        • HonorHealth
        • Kontakt:
          • Telefonnummer: 480-323-1350
        • Ledende efterforsker:
          • Muhammad Khawaja
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Rekruttering
        • University of California, San Diego (UCSD) - Moores Cancer Center
        • Ledende efterforsker:
          • Ramez Eskander
        • Kontakt:
          • Telefonnummer: 858-657-7000
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Rekruttering
        • Emory University
        • Ledende efterforsker:
          • Beryl Manning-Geist
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • Rekruttering
        • South Texas Accelerated Research Therapeutics (START) Midwest
        • Ledende efterforsker:
          • Nehal Lakhani
        • Kontakt:
          • Telefonnummer: 616-389-1652
    • New York
      • Mineola, New York, Forenede Stater, 11501
        • Rekruttering
        • NYU Langone Health - Long Island
        • Ledende efterforsker:
          • Bhavana Pothuri
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
        • Ledende efterforsker:
          • Chrisann Kyi
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • New York University (NYU) Clinical Cancer Center
        • Ledende efterforsker:
          • Bhavana Pothuri
        • Kontakt:
          • Telefonnummer: 212-731-5100
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University (OSU) Wexner Medical Center
        • Ledende efterforsker:
          • David O'Malley
    • Texas
      • Houston, Texas, Forenede Stater, 77030-4000
        • Rekruttering
        • The University of Texas - MD Anderson Cancer Center
        • Ledende efterforsker:
          • Shannon Westin
    • Utah
      • West Valley City, Utah, Forenede Stater, 84119
        • Rekruttering
        • START Mountain Region
        • Ledende efterforsker:
          • William McKean
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Ikke rekrutterer endnu
        • Inova Schar Cancer Institute
        • Ledende efterforsker:
          • Leslie Randall
  • Frankrig
      • Lyon, Frankrig, 69373
        • Rekruttering
        • Centre Leon Berard
        • Ledende efterforsker:
          • Isabelle Ray-Coquard
        • Kontakt:
          • Telefonnummer: +33478782644
      • Saint-Herblain, Frankrig, 44805
        • Rekruttering
        • Institut de Cancerologie de l'Ouest - site St-Herblain
        • Ledende efterforsker:
          • Mario Campone
        • Kontakt:
          • Telefonnummer: +33 02 40 67 99 00
      • Toulouse, Frankrig, 31059
        • Rekruttering
        • Oncopole Claudius Regaud
        • Ledende efterforsker:
          • Carlos Gomez-Roca
  • Italien
      • Milan, Italien, 20141
        • Rekruttering
        • Istituto Europeo di Oncologia
        • Ledende efterforsker:
          • Giuseppe Curigliano
        • Kontakt:
          • Telefonnummer: +39 02 5748 9599
      • Milan, Italien, 20159
        • Rekruttering
        • Humanitas San Pio X
        • Ledende efterforsker:
          • Domenica Lorusso
  • Japan
      • Shizuoka, Japan, 411-8777
        • Rekruttering
        • Shizuoka Cancer Center
        • Kontakt:
          • Telefonnummer: 81120023812
        • Ledende efterforsker:
          • Haruyasu Murakami
      • Tokyo, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
        • Kontakt:
          • Telefonnummer: 81120023812
        • Ledende efterforsker:
          • Takafumi Koyama
      • Tokyo, Japan, 135-8550
        • Rekruttering
        • Cancer Institute Hospital of JFCR
        • Ledende efterforsker:
          • Shigehisa Kitano
        • Kontakt:
          • Telefonnummer: 81120023812
  • Spanien
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitario Vall d'Hebron
        • Kontakt:
          • Telefonnummer: +34 932543450
        • Ledende efterforsker:
          • Roberta Mazzeo
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
        • Kontakt:
          • Telefonnummer: +34 913908922
        • Ledende efterforsker:
          • Ainhoa Madariaga Urrutia
      • Valencia, Spanien, 46010
        • Rekruttering
        • Hospital Clinico Universitario de Valencia
        • Ledende efterforsker:
          • Jose Alejandro Perez Fidalgo
        • Kontakt:
          • Telefonnummer: +34 961973527
  • Sydkorea
      • Goyang-si Gyeonggi-do, Sydkorea, 10408
        • Rekruttering
        • National Cancer Center
        • Ledende efterforsker:
          • Myong Cheol Lim
        • Kontakt:
          • Telefonnummer: 82-1588-8110

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:

  • Have one of the following solid tumor cancers:

    • Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)
    • Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer
    • Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, TNBC, and high grade endometrioid cancer

Exclusion Criteria:

  • Individual with known or suspected uncontrolled central nervous system (CNS) metastases
  • Individual with history of carcinomatous meningitis
  • Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Individual with evidence of corneal keratopathy or history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
  • History of pneumonitis/interstitial lung disease
  • 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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sofe-M (Dose-escalation, Cohort A1)

Escalating doses of Sofe-M administered intravenously (IV)
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Eksperimentel: Sofe-M (Cohort A1 Parts A and C)

Sofe-M administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Eksperimentel: Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)

Sofe-M administered IV and itraconazole administered orally
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Medicin: Itraconazole

oral
Eksperimentel: Sofe-M (Dose-optimization, Cohort A2)

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Eksperimentel: Sofe-M (Enrichment Cohort A3)

Monotherapy administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Eksperimentel: Sofe-M (Combination Cohort A4)

Combination with bevacizumab administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Medicin: bevacizumab

IV
Eksperimentel: Sofe-M (Combination Cohort A5)

Combination with carboplatin administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Medicin: carboplatin

IV
Eksperimentel: Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Medicin: pembrolizumab

IV
Eksperimentel: Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Medicin: bevacizumab

IV

Medicin: carboplatin

IV
Eksperimentel: Sofe-M (Dose-expansion, Cohort B2-B4)

Sofe-M administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156
Eksperimentel: Sofe-M (Dose-expansion, Cohort B1)

Sofe-M administered IV
Medicin: Sofe-M

Intravenous

Andre navne:
  • sofetabart mipitecan
  • LY4170156

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)
Tidsramme: 1 Cycle (21 or 28 days)

Number of participants with dose-limiting toxicities (DLTs)
1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab
Tidsramme: 1 Cycle (21 or 28 days)

Number of participants with DLTs
1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin
Tidsramme: 1 Cycle (21 or 28 days)

Number of participants with DLTs
1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab
Tidsramme: 1 Cycle (21 or 28 days)

Number of participants with DLTs
1 Cycle (21 or 28 days)
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)
Tidsramme: Up to Approximately 60 Months or 5 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to Approximately 60 Months or 5 Years
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR
Tidsramme: Up to Approximately 60 Months or 5 Years

ORR per RECIST 1.1
Up to Approximately 60 Months or 5 Years
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Tidsramme: Up to Approximately 60 Months or 5 Years

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Up to Approximately 60 Months or 5 Years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)
Tidsramme: First 4 Cycles (84 days)

PK: Cmin of Sofe-M (LY4170156)
First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin
Tidsramme: First 4 Cycles (Approximately 84 days)

PK: Cmin of Sofe-M (LY4170156)
First 4 Cycles (Approximately 84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab
Tidsramme: First 4 Cycles (84 days)

PK: Cmin of Sofe-M (LY4170156)
First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)
Tidsramme: First 4 Cycles (84 days)

PK: AUC of Sofe-M (LY4170156)
First 4 Cycles (84 days)
To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)
Tidsramme: Up to Approximately 60 Months or 5 Years

PRO-CTCAE of Sofe-M (LY4170156)
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)
Tidsramme: Up to Approximately 60 Months or 5 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab
Tidsramme: Up to Approximately 60 Months or 5 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)
Tidsramme: Up to Approximately 60 Months or 5 Years

DOR per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab
Tidsramme: Up to Approximately 60 Months or 5 Years

DOR per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)
Tidsramme: Up to Approximately 60 Months or 5 Years

TTR per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab
Tidsramme: Up to Approximately 60 Months or 5 Years

TTR per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)
Tidsramme: Up to Approximately 60 Months or 5 Years

PFS per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab
Tidsramme: Up to Approximately 60 Months or 5 Years]

PFS per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years]
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)
Tidsramme: Up to Approximately 60 Months or 5 Years

DCR per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab
Tidsramme: Up to Approximately 60 Months or 5 Years

DCR per investigator assessed RECIST 1.1
Up to Approximately 60 Months or 5 Years

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

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.

Generelle publikationer

Hjælpsomme links

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)

20. maj 2024

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

30. april 2024

Først indsendt, der opfyldte QC-kriterier

1. maj 2024

Først opslået (Faktiske)

6. maj 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

Andre undersøgelses-id-numre

  • 18863
  • LOXO-FRA-24001 (Anden identifikator: Eli Lilly and Company)
  • 2024-511238-11-00 (Ctis)
  • J5E-OX-JZXA (Anden identifikator: Eli Lilly and Company)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD-delingstidsramme

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD-delingsadgangskriterier

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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 .

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