A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

NCT06400472 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 188632024-511238-11-00J5E-OX-JZXALOXO-FRA-24001
• Study Type: interventional
• Target: 495
• Locations: 7 countries
• Sites: 23

Brief 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.

Conditions

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

Keywords

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; sofe-m

Outcome Measures

Primary Outcomes (6)

• 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)

• 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

• 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 Outcomes (14)

• To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)

  First 4 Cycles (84 days)

• To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin

  First 4 Cycles (Approximately 84 days)

• To characterize the PK properties of LY4170156: Cmin with pembrolizumab

  First 4 Cycles (84 days)

• To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)

  First 4 Cycles (84 days)

• To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)

  Up to Approximately 48 Months or 4 Years

Study Arms (9)

LY4170156 (Dose-escalation, Cohort A1)

EXPERIMENTAL

Escalating doses of LY4170156 administered intravenously (IV)

Drug: LY4170156

LY4170156 (Cohort A1 Parts A and C)

EXPERIMENTAL

LY4170156 administered IV

Drug: LY4170156

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

EXPERIMENTAL

LY4170156 administered IV and itraconazole administered orally

Drug: LY4170156; Drug: Itraconazole

LY4170156 (Dose-optimization, Cohort A2)

EXPERIMENTAL

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

Drug: LY4170156

LY4170156 (Enrichment Cohort A3)

EXPERIMENTAL

Monotherapy administered IV

Drug: LY4170156

LY4170156 (Combination Cohort A4)

EXPERIMENTAL

Combination with bevacizumab administered IV

Drug: LY4170156; Drug: bevacizumab

LY4170156 (Combination Cohort A5)

EXPERIMENTAL

Combination with carboplatin administered IV

Drug: LY4170156; Drug: carboplatin

LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)

EXPERIMENTAL

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

Drug: LY4170156; Drug: pembrolizumab

LY4170156 (Dose-expansion, Cohort B1-B4)

EXPERIMENTAL

LY4170156 administered IV

Drug: LY4170156

Interventions

LY4170156 DRUG

Intravenous

Also known as: sofetabart mipitecan

LY4170156 (Cohort A1 Parts A and C); LY4170156 (Combination Cohort A4); LY4170156 (Combination Cohort A5); LY4170156 (Dose-escalation, Cohort A1); LY4170156 (Dose-expansion, Cohort B1-B4); LY4170156 (Dose-optimization, Cohort A2); LY4170156 (Enrichment Cohort A3); LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B); LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)

bevacizumab DRUG

IV

LY4170156 (Combination Cohort A4)

carboplatin DRUG

IV

LY4170156 (Combination Cohort A5)

Itraconazole DRUG

oral

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

pembrolizumab DRUG

IV

LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (23)

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

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

La Jolla, California, 92037, United States

RECRUITING

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

NYU Langone Health - Long Island

Mineola, New York, 11501, United States

RECRUITING

New York University (NYU) Clinical Cancer Center

New York, New York, 10016, United States

RECRUITING

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

New York, New York, 10065, United States

RECRUITING

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

Cancer Research SA

Adelaide, 5000, Australia

RECRUITING

Icon Cancer Centre South Brisbane

QLD, 4101, Australia

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

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

Saint-Herblain, 44805, France

RECRUITING

Oncopole Claudius Regaud

Toulouse, 31059, France

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Tokyo, 104-0045, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Related Links

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

MeSH Terms

Conditions

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

Interventions

Bevacizumab; Carboplatin; Itraconazole; pembrolizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

ES (3); KR (1); FR (3); AU (2); IT (2); US (9); JP (3)