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NCT06400472PHASE1Recruiting

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Eli Lilly and Company

Start Date

5/20/2024

Completion Date

4/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

LY4170156

DRUG

bevacizumab

DRUG

carboplatin

DRUG

Itraconazole

DRUG

pembrolizumab

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Conditions

Ovarian NeoplasmsEndometrial NeoplasmsUterine Cervical NeoplasmsCarcinoma, Non-Small-Cell LungTriple Negative Breast NeoplasmsPancreatic NeoplasmColorectal Neoplasms

Locations

HonorHealth

Scottsdale, Arizona 85258

United States

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

La Jolla, California 92037

United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan 49546

United States

NYU Langone Health - Long Island

Mineola, New York 11501

United States

New York University (NYU) Clinical Cancer Center

New York, New York 10016

United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio 43210

United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas 77030-4000

United States

START Mountain Region

West Valley City, Utah 84119

United States

Cancer Research SA

Adelaide, 5000

Australia

Icon Cancer Centre South Brisbane

QLD, 4101

Australia

Centre Leon Berard

Lyon, 69373

France

Institut de Cancerologie de l'Ouest - site St-Herblain

Saint-Herblain, 44805

France

Oncopole Claudius Regaud

Toulouse, 31059

France

Humanitas San Pio X

Milan, 20159

Italy

Istituto Europeo di Oncologia

Milan, 20141

Italy

Shizuoka Cancer Center

Shizuoka, 411-8777

Japan

National Cancer Center Hospital

Tokyo, 104-0045

Japan

Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

National Cancer Center

Goyang-si Gyeonggi-do, 10408

South Korea

Hospital Universitario Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain