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En studie av LY4170156 hos deltakere med utvalgte avanserte solide svulster

3. november 2026 oppdatert av: Eli Lilly and Company

En første-i-menneske, fase 1a/1b-studie for å vurdere sikkerheten, toleransen og den foreløpige effekten av LY4170156, et antistoff-medikamentkonjugat rettet mot folatreseptor α-uttrykkende tumorceller, hos deltakere med utvalgte avanserte solide svulster

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

575

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

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:

    • 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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

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

Intravenous

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

Sofe-M administered IV
Legemiddel: Sofe-M

Intravenous

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

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

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Legemiddel: Itraconazole

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

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

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Eksperimentell: Sofe-M (Enrichment Cohort A3)

Monotherapy administered IV
Legemiddel: Sofe-M

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Eksperimentell: Sofe-M (Combination Cohort A4)

Combination with bevacizumab administered IV
Legemiddel: Sofe-M

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Legemiddel: bevacizumab

IV
Eksperimentell: Sofe-M (Combination Cohort A5)

Combination with carboplatin administered IV
Legemiddel: Sofe-M

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Legemiddel: carboplatin

IV
Eksperimentell: 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
Legemiddel: Sofe-M

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Legemiddel: pembrolizumab

IV
Eksperimentell: 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
Legemiddel: Sofe-M

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156
Legemiddel: bevacizumab

IV

Legemiddel: carboplatin

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

Sofe-M administered IV
Legemiddel: Sofe-M

Intravenous

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

Sofe-M administered IV
Legemiddel: Sofe-M

Intravenous

Andre navn:
  • sofetabart mipitecan
  • LY4170156

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

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.

Generelle publikasjoner

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)

20. mai 2024

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

30. april 2024

Først innsendt som oppfylte QC-kriteriene

1. mai 2024

Først lagt ut (Faktiske)

6. mai 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

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