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A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

NCT ID: NCT06400472

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY4170156 (Dose-escalation, Cohort A1)

Escalating doses of LY4170156 administered intravenously (IV)

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

LY4170156 (Cohort A1 Parts A and C)

LY4170156 administered IV

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)

LY4170156 administered IV and itraconazole administered orally

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

Itraconazole

Intervention Type DRUG

oral

LY4170156 (Dose-optimization, Cohort A2)

Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

LY4170156 (Enrichment Cohort A3)

Monotherapy administered IV

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

LY4170156 (Combination Cohort A4)

Combination with bevacizumab administered IV

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

bevacizumab

Intervention Type DRUG

IV

LY4170156 (Combination Cohort A5)

Combination with carboplatin administered IV

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

carboplatin

Intervention Type DRUG

IV

LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)

Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

pembrolizumab

Intervention Type DRUG

IV

LY4170156 (Dose-expansion, Cohort B1-B4)

LY4170156 administered IV

Group Type EXPERIMENTAL

LY4170156

Intervention Type DRUG

Intravenous

Interventions

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LY4170156

Intravenous

Intervention Type DRUG

bevacizumab

IV

Intervention Type DRUG

carboplatin

IV

Intervention Type DRUG

Itraconazole

oral

Intervention Type DRUG

pembrolizumab

IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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HonorHealth

Scottsdale, Arizona, United States

Site Status RECRUITING

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

La Jolla, California, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

NYU Langone Health - Long Island

Mineola, New York, United States

Site Status RECRUITING

New York University (NYU) Clinical Cancer Center

New York, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

START Mountain Region

West Valley City, Utah, United States

Site Status RECRUITING

Cancer Research SA

Adelaide, , Australia

Site Status RECRUITING

Icon Cancer Centre South Brisbane

South Brisbane, , Australia

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

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

Saint-Herblain, , France

Site Status RECRUITING

Oncopole Claudius Regaud

Toulouse, , France

Site Status RECRUITING

Istituto Europeo di Oncologia

Milan, , Italy

Site Status RECRUITING

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status RECRUITING

Shizuoka Cancer Center

Shizuoka, , Japan

Site Status RECRUITING

National Cancer Center Hospital

Tokyo, , Japan

Site Status RECRUITING

Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status RECRUITING

National Cancer Center

Gyeonggi-do, , South Korea

Site Status RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Countries

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United States Australia France Italy Japan South Korea Spain

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Related Links

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https://trials.lilly.com/en-US/trial/482318

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Other Identifiers

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J5E-OX-JZXA

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-FRA-24001

Identifier Type: OTHER

Identifier Source: secondary_id

2024-511238-11-00

Identifier Type: CTIS

Identifier Source: secondary_id

18863

Identifier Type: -

Identifier Source: org_study_id