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A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

NCT06400472 · Eli Lilly and Company
In plain English

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Official title
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
About this study
The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. 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.
Eligibility criteria
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, and TNBC 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
Study design
Enrollment target: 495 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-20
Estimated completion: 2027-04
Last updated: 2026-01-14
Interventions
Drug: LY4170156Drug: bevacizumabDrug: carboplatinDrug: ItraconazoleDrug: pembrolizumab
Primary outcomes
  • Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 (1 Cycle (21 days))
  • Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab (1 Cycle (21 days))
  • Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin (1 Cycle (21 days))
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (23)
HonorHealthRecruiting
Scottsdale, Arizona, United States
University of California, San Diego (UCSD) - Moores Cancer CenterRecruiting
La Jolla, California, United States
South Texas Accelerated Research Therapeutics (START) MidwestRecruiting
Grand Rapids, Michigan, United States
NYU Langone Health - Long IslandRecruiting
Mineola, New York, United States
New York University (NYU) Clinical Cancer CenterRecruiting
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
The Ohio State University (OSU) Wexner Medical CenterRecruiting
Columbus, Ohio, United States
The University of Texas - MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
Cancer Research SARecruiting
Adelaide, Australia
Icon Cancer Centre South BrisbaneRecruiting
QLD, Australia
Centre Leon BerardRecruiting
Lyon, France
Institut de Cancerologie de l'Ouest - site St-HerblainRecruiting
Saint-Herblain, France
Oncopole Claudius RegaudRecruiting
Toulouse, France
Istituto Europeo di OncologiaRecruiting
Milan, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Shizuoka Cancer CenterRecruiting
Shizuoka, Japan
National Cancer Center HospitalRecruiting
Tokyo, Japan
Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan
National Cancer CenterRecruiting
Goyang-si Gyeonggi-do, South Korea
Hospital Universitario Vall d'HebronRecruiting
Barcelona, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors · TrialPath