A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Description

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.

Conditions

Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms

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Study Overview

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Study Details

Study overview

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.

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

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Condition
Ovarian Neoplasms
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health Research Institute, Scottsdale, Arizona, United States, 85258

Grand Rapids

South Texas Accelerated Research Therapeutics (START), Grand Rapids, Michigan, United States, 49546

New York

NYU Langone Health, New York, New York, United States, 10016

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Columbus

Ohio State University Medical Center, Columbus, Ohio, United States, 43210

West Valley City

START Mountain Region, West Valley City, Utah, United States, 84119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have one of the following solid tumor cancers:
  • * Cohort A1: 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, and colorectal cancer (CRC)
  • * Cohort A2/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
  • * Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Emin Avsar, STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-04