A Study Of LY4170156 In Participants With Selected Advanced Solid Tumors

Study Overview

A Study of LY4170156 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.

N/A

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

DRUG: LY4170156
DRUG: Bevacizumab
DRUG: carboplatin

18863
J5E-OX-JZXA (OTHER Identifier) (OTHER: Eli Lilly and Company)
LOXO-FRA-24001 (OTHER Identifier) (OTHER: Eli Lilly and Company)
2024-511238-11-00 (CTIS Identifier) (CTIS: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-04-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-03
First Submitted that Met QC Criteria 2024-05-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-09
First Posted (ESTIMATED) 2024-05-06	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: LY4170156 (Dose-escalation, Cohort A1) Escalating doses of LY4170156 administered intravenously (IV).	DRUG: LY4170156 Intravenous
EXPERIMENTAL: LY4170156 (Dose-optimization, Cohort A2) Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.	DRUG: LY4170156 Intravenous
EXPERIMENTAL: LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2) LY4170156 administered IV.	DRUG: LY4170156 Intravenous
EXPERIMENTAL: LY4170156 (Enrichment Cohort A3) Monotherapy administered IV	DRUG: LY4170156 Intravenous
EXPERIMENTAL: LY4170156 (Combination Cohort A4) Combination with bevacizumab administered IV	DRUG: LY4170156 Intravenous DRUG: Bevacizumab IV
EXPERIMENTAL: LY4170156 (Combination Cohort A5) Combination with carboplatin administered IV	DRUG: LY4170156 Intravenous DRUG: carboplatin IV

Primary Outcome Measures	Measure Description	Time Frame
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 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

Secondary Outcome Measures	Measure Description	Time Frame
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)	PK: Cmin of LY4170156	First 4 Cycles (84 days)
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) with vevacizumab or carboplatin	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 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: Overall response rate (ORR) with bevacizumab or carboplatin	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: Duration of response (DOR) with bevacizumab or carboplatin	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: Time to response (TTR) with bevacizumab or carboplatin	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: Progression free survival (PFS) with bevacizumab or carboplatin	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 evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin	DCR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years]

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone Number: 13176154559

Email: clinical_inquiry_hub@lilly.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Have one of the following solid tumor cancers:

Cohort A1: 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, and colorectal cancer (CRC)
Cohort A2/A3/A4/A5/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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