RECRUITING

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

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Conditions

Ovarian NeoplasmsEndometrial NeoplasmsUterine Cervical NeoplasmsCarcinoma, Non-Small-Cell LungTriple Negative Breast NeoplasmsPancreatic NeoplasmColorectal NeoplasmsFolate receptor alphaNSCLCOvarian cancerCervical cancerEndometrial cancerSolid tumorLung cancerBreast cancerPancreatic cancerColorectal cancerAnti-drug conjugatePhase IChemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-05-06
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06400472

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have one of the following solid tumor cancers:
  2. * 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)
  3. * Cohort A2/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
  4. * Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer
  1. * Individual with known or suspected uncontrolled central nervous system (CNS) metastases
  2. * Individual with history of carcinomatous meningitis
  3. * Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  4. * Individual with evidence of corneal keratopathy or history of corneal transplant
  5. * Any serious unresolved toxicities from prior therapy
  6. * Significant cardiovascular disease
  7. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
  8. * History of pneumonitis/interstitial lung disease
  9. * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
13176154559
ClinicalTrials.gov@lilly.com

Principal Investigator

Emin Avsar
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Honor Health Research Institute
Scottsdale, Arizona, 85258
United States
South Texas Accelerated Research Therapeutics (START)
Grand Rapids, Michigan, 49546
United States
NYU Langone Health
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Emin Avsar, STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-06
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-05-06
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Folate receptor alpha
  • NSCLC
  • Ovarian cancer
  • Cervical cancer
  • Endometrial cancer
  • Solid tumor
  • Lung cancer
  • Breast cancer
  • Pancreatic cancer
  • Colorectal cancer
  • Anti-drug conjugate
  • Phase I
  • Chemotherapy

Additional Relevant MeSH Terms

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