Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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/A3/A4/A5/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
    • Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego (UCSD) - Moores Cancer Center accepting new patients
    La Jolla 5363943 California 5332921 92037 United States
  • HonorHealth accepting new patients
    Scottsdale 5313457 Arizona 5551752 85258 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
ID
NCT06400472
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated