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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4170156 (Dose-escalation, Cohort A1) 		Escalating doses of LY4170156 administered intravenously (IV)
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
Experimental
LY4170156 (Cohort A1 Parts A and C) 		LY4170156 administered IV
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
Experimental
LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) 		LY4170156 administered IV and itraconazole administered orally
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
  • Drug: Itraconazole
    oral
Experimental
LY4170156 (Dose-optimization, Cohort A2) 		Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
Experimental
LY4170156 (Enrichment Cohort A3) 		Monotherapy administered IV
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
Experimental
LY4170156 (Combination Cohort A4) 		Combination with bevacizumab administered IV
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
  • Drug: bevacizumab
    IV
Experimental
LY4170156 (Combination Cohort A5) 		Combination with carboplatin administered IV
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
  • Drug: carboplatin
    IV
Experimental
LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6) 		Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan
  • Drug: pembrolizumab
    IV
Experimental
LY4170156 (Dose-expansion, Cohort B1-B4) 		LY4170156 administered IV
  • Drug: LY4170156
    Intravenous
    Other names:
    • sofetabart mipitecan

Recruiting Locations

HonorHealth
Scottsdale, Arizona 85258

University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California 92037

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

NYU Langone Health - Long Island
Mineola, New York 11501

New York University (NYU) Clinical Cancer Center
New York, New York 10016

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York 10065

The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio 43210

The University of Texas - MD Anderson Cancer Center
Houston, Texas 77030-4000

START Mountain Region
West Valley City, Utah 84119

More Details

NCT ID
NCT06400472
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center