A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Triple Negative Breast Neoplasms; Pancreatic Neoplasm
• Intervention / Treatment: Drug: carboplatin; Drug: Itraconazole; Drug: bevacizumab; Drug: LY4170156; Drug: pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 495
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Cancer Research SA
  • QLD, Australia, 4101
    • Recruiting
    • Icon Cancer Centre South Brisbane
• France
  • Lyon, France, 69373
    • Recruiting
    • Centre léon bérard
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancerologie de l'Ouest - site St-Herblain
  • Toulouse, France, 31059
    • Recruiting
    • Oncopole Claudius Regaud
• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia
  • Rozzano, Italy, 20089
    • Recruiting
    • Istituto Clinico Humanitas
• Japan
  • Shizuoka, Japan, 411-8777
    • Recruiting
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • Recruiting
    • Cancer Institute Hospital of JFCR
• South Korea
  • Goyang-si Gyeonggi-do, South Korea, 10408
    • Recruiting
    • National Cancer Center
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de octubre
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • HonorHealth
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California, San Diego (UCSD) - Moores Cancer Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • South Texas Accelerated Research Therapeutics (START) Midwest
  • New York
    • Mineola, New York, United States, 11501
      • Recruiting
      • NYU Langone Health - Long Island
    • New York, New York, United States, 10065
      • Recruiting
      • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • Recruiting
      • New York University (NYU) Clinical Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University (OSU) Wexner Medical Center
  • Texas
    • Houston, Texas, United States, 77030-4000
      • Recruiting
      • The University of Texas - MD Anderson Cancer Center
  • Utah
    • West Valley City, Utah, United States, 84119
      • Recruiting
      • START Mountain Region
      • Contact: Phone Number: 855-569-6305

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: bevacizumab; IV; Drug: LY4170156; Intravenous; Other Names: sofetabart mipitecan
Experimental: LY4170156 (Combination Cohort A5); Combination with carboplatin administered IV	Drug: carboplatin; IV; Drug: LY4170156; Intravenous; Other Names: sofetabart mipitecan
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: Itraconazole; oral; Drug: LY4170156; Intravenous; Other Names: sofetabart mipitecan
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156	Number of participants with dose-limiting toxicities (DLTs)	1 Cycle (21 days)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab	Number of participants with DLTs	1 Cycle (21 days)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin	Number of participants with DLTs	1 Cycle (21 days)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab	Number of participants with DLTs	1 Cycle (21 days)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module	Up to Approximately 48 Months or 4 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR)	DOR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)	TTR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)	PFS per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)	DCR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)	PK: Cmin of LY4170156	First 4 Cycles (84 days)
To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)	PK: AUC of LY4170156	First 4 Cycles (84 days)
To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin	PK: Cmin of LY4170156	First 4 Cycles (Approximately 84 days)
To characterize the PK properties of LY4170156: Cmin with pembrolizumab	PK: Cmin of LY4170156	First 4 Cycles (84 days)
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab	DOR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab	TTR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab	PFS per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years]
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab	DCR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Colorectal cancer; Breast cancer; Ovarian cancer; Lung cancer; Phase I; Chemotherapy; Solid tumor; Pancreatic cancer; Cervical cancer; Endometrial cancer; Folate receptor alpha; Anti-drug conjugate; sofe-m
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Uterine Cervical Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Uterine Neoplasms; Skin and Connective Tissue Diseases; Lung Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Triple Negative Breast Neoplasms; Endometrial Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Triazoles; Piperazines; Bevacizumab; Carboplatin; Itraconazole; pembrolizumab
• Other Study ID Numbers: 18863; LOXO-FRA-24001 (Other Identifier: Eli Lilly and Company); 2024-511238-11-00 (Ctis); J5E-OX-JZXA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No