RecruitingInterventionalPhase 1

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

NCT ID: NCT06400472Sponsor: Eli Lilly and CompanyLast updated: 2026-06-18

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.

Arms & interventions

DrugLY4170156
Intravenous
Drugbevacizumab
IV
Drugcarboplatin
IV
DrugItraconazole
oral
Drugpembrolizumab
IV

Outcome measures

Primary

Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156
Number of participants with dose-limiting toxicities (DLTs)
Time frame: 1 Cycle (21 days)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab
Number of participants with DLTs
Time frame: 1 Cycle (21 days)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin
Number of participants with DLTs
Time frame: 1 Cycle (21 days)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab
Number of participants with DLTs
Time frame: 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)
Time frame: 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
Time frame: Up to Approximately 48 Months or 4 Years

Secondary

To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)
Time frame: First 4 Cycles (84 days)
To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin
Time frame: First 4 Cycles (Approximately 84 days)
To characterize the PK properties of LY4170156: Cmin with pembrolizumab
Time frame: First 4 Cycles (84 days)
To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)
Time frame: First 4 Cycles (84 days)
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR)
Time frame: 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
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)
Time frame: 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
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)
Time frame: 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
Time frame: Up to Approximately 48 Months or 4 Years]
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)
Time frame: 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
Time frame: Up to Approximately 48 Months or 4 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (9)

HonorHealth

Scottsdale, Arizona, 85258

Recruiting

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

La Jolla, California, 92037

Recruiting

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546

Recruiting

NYU Langone Health - Long Island

Mineola, New York, 11501

Recruiting

New York University (NYU) Clinical Cancer Center

New York, New York, 10016

Recruiting

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

New York, New York, 10065

Recruiting

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, 43210

Recruiting

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4000

Recruiting

START Mountain Region

West Valley City, Utah, 84119

Recruiting