A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

NCT06400472
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
575
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Lead sponsor
Eli Lilly and Company
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Start date
2024-05-20
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Number of sites
25
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Summary
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.
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Short title
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
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Official title
A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-06-01
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First posted
2024-05-06
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Registry last updated
2026-10-07
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Primary completion date
2029-06-01
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Start date
2024-05-20
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Participants
575
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Participant count basis
Estimated
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Planned participants
575
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Protocol amendments
7
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Number of sites
25
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06400472
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ClinicalTrials.gov ID
NCT06400472
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)

    Timeframe: 1 Cycle (21 or 28 days)

    Number of participants with dose-limiting toxicities (DLTs)

  2. Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab

    Timeframe: 1 Cycle (21 or 28 days)

    Number of participants with DLTs

  3. Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin

    Timeframe: 1 Cycle (21 or 28 days)

    Number of participants with DLTs

  4. Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab

    Timeframe: 1 Cycle (21 or 28 days)

    Number of participants with DLTs

  5. Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)

    Timeframe: Up to Approximately 60 Months or 5 Years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  6. Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR

    Timeframe: Up to Approximately 60 Months or 5 Years

    ORR per RECIST 1.1

  7. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Timeframe: Up to Approximately 60 Months or 5 Years

    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

  1. To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)

    Timeframe: First 4 Cycles (84 days)

    PK: Cmin of Sofe-M (LY4170156)

  2. To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin

    Timeframe: First 4 Cycles (Approximately 84 days)

    PK: Cmin of Sofe-M (LY4170156)

  3. To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab

    Timeframe: First 4 Cycles (84 days)

    PK: Cmin of Sofe-M (LY4170156)

  4. To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)

    Timeframe: First 4 Cycles (84 days)

    PK: AUC of Sofe-M (LY4170156)

  5. To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)

    Timeframe: Up to Approximately 60 Months or 5 Years

    PRO-CTCAE of Sofe-M (LY4170156)

  6. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)

    Timeframe: Up to Approximately 60 Months or 5 Years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  7. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab

    Timeframe: Up to Approximately 60 Months or 5 Years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  8. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)

    Timeframe: Up to Approximately 60 Months or 5 Years

    DOR per investigator assessed RECIST 1.1

  9. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab

    Timeframe: Up to Approximately 60 Months or 5 Years

    DOR per investigator assessed RECIST 1.1

  10. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)

    Timeframe: Up to Approximately 60 Months or 5 Years

    TTR per investigator assessed RECIST 1.1

  11. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab

    Timeframe: Up to Approximately 60 Months or 5 Years

    TTR per investigator assessed RECIST 1.1

  12. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)

    Timeframe: Up to Approximately 60 Months or 5 Years

    PFS per investigator assessed RECIST 1.1

  13. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab

    Timeframe: Up to Approximately 60 Months or 5 Years]

    PFS per investigator assessed RECIST 1.1

  14. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)

    Timeframe: Up to Approximately 60 Months or 5 Years

    DCR per investigator assessed RECIST 1.1

  15. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab

    Timeframe: Up to Approximately 60 Months or 5 Years

    DCR per investigator assessed RECIST 1.1

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • HonorHealthScottsdale, United StatesRecruiting
  • University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Emory UniversityAtlanta, United StatesNot yet recruiting
  • South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesRecruiting
  • NYU Langone Health - Long IslandMineola, United StatesRecruiting
  • New York University (NYU) Clinical Cancer CenterNew York, United StatesRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • The Ohio State University (OSU) Wexner Medical CenterColumbus, United StatesRecruiting
  • The University of Texas - MD Anderson Cancer CenterHouston, United StatesRecruiting
  • START Mountain RegionWest Valley City, United StatesRecruiting
  • Inova Schar Cancer InstituteFalls Church, United StatesNot yet recruiting
  • Cancer Research SAAdelaide, AustraliaRecruiting
  • Icon Cancer Centre South BrisbaneQLD, AustraliaRecruiting
  • Centre Leon BerardLyon, FranceRecruiting
  • Institut de Cancerologie de l'Ouest - site St-HerblainSaint-Herblain, FranceRecruiting
  • Oncopole Claudius RegaudToulouse, FranceRecruiting
  • Humanitas San Pio XMilan, ItalyRecruiting
  • Istituto Europeo di OncologiaMilan, ItalyRecruiting
  • Shizuoka Cancer CenterShizuoka, JapanRecruiting
  • National Cancer Center HospitalTokyo, JapanRecruiting
  • Cancer Institute Hospital of JFCRTokyo, JapanRecruiting
  • National Cancer CenterGoyang-si Gyeonggi-do, South KoreaRecruiting
  • Hospital Universitario Vall d'HebronBarcelona, SpainRecruiting
  • Hospital Universitario 12 de OctubreMadrid, SpainRecruiting
  • Hospital Clinico Universitario de ValenciaValencia, SpainRecruiting
Sources for sites
clinicaltrials.gov

  • 2024-511238-11-00
  • J5E-OX-JZXA
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (9)

Targets (2)