> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly4170156-in-participants-with-selected-advanced-acae1ed9-c9ee-4b50-b282-df71b7eb550a > Record changed: 2026-10-13 # A Study of LY4170156 in Participants With Selected Advanced Solid Tumors NCT06400472 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) Participants 495 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) Start date 2024-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) Number of sites 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Short title** A Study of LY4170156 in Participants With Selected Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Dates **Completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **First posted** 2024-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Registry last updated** 2026-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Primary completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Start date** 2024-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Size and sites **Participants** 495 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Planned participants** 495 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Number of sites** 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Identifiers **Registry ID** NCT06400472 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **ClinicalTrials.gov ID** NCT06400472 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Outcomes ### Primary outcomes 1. Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 Timeframe: 1 Cycle (21 days) Number of participants with dose-limiting toxicities (DLTs) 2. Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab Timeframe: 1 Cycle (21 days) Number of participants with DLTs 3. Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin Timeframe: 1 Cycle (21 days) Number of participants with DLTs 4. Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab Timeframe: 1 Cycle (21 days) Number of participants with DLTs 5. Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR) Timeframe: Up to Approximately 48 Months or 4 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) 6. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Timeframe: Up to Approximately 48 Months or 4 Years A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module ### Secondary outcomes 1. To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) Timeframe: First 4 Cycles (84 days) PK: Cmin of LY4170156 2. To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin Timeframe: First 4 Cycles (Approximately 84 days) PK: Cmin of LY4170156 3. To characterize the PK properties of LY4170156: Cmin with pembrolizumab Timeframe: First 4 Cycles (84 days) PK: Cmin of LY4170156 4. To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC) Timeframe: First 4 Cycles (84 days) PK: AUC of LY4170156 5. To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) Timeframe: Up to Approximately 48 Months or 4 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) 6. To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab Timeframe: Up to Approximately 48 Months or 4 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) 7. To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) Timeframe: Up to Approximately 48 Months or 4 Years DOR per investigator assessed RECIST 1.1 8. To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab Timeframe: Up to Approximately 48 Months or 4 Years DOR per investigator assessed RECIST 1.1 9. To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) Timeframe: Up to Approximately 48 Months or 4 Years TTR per investigator assessed RECIST 1.1 10. To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab Timeframe: Up to Approximately 48 Months or 4 Years TTR per investigator assessed RECIST 1.1 11. To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) Timeframe: Up to Approximately 48 Months or 4 Years PFS per investigator assessed RECIST 1.1 12. To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab Timeframe: Up to Approximately 48 Months or 4 Years\] PFS per investigator assessed RECIST 1.1 13. To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) Timeframe: Up to Approximately 48 Months or 4 Years DCR per investigator assessed RECIST 1.1 14. To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab Timeframe: Up to Approximately 48 Months or 4 Years DCR per investigator assessed RECIST 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Sites - HonorHealthScottsdale, United StatesRecruiting - University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, United StatesRecruiting - South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesRecruiting - NYU Langone Health - Long IslandMineola, United StatesRecruiting - New York University (NYU) Clinical Cancer CenterNew York, United StatesRecruiting - David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - The Ohio State University (OSU) Wexner Medical CenterColumbus, United StatesRecruiting - The University of Texas - MD Anderson Cancer CenterHouston, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting - Cancer Research SAAdelaide, AustraliaRecruiting - Icon Cancer Centre South BrisbaneQLD, AustraliaRecruiting - Centre Leon BerardLyon, FranceRecruiting - Institut de Cancerologie de l'Ouest - site St-HerblainSaint-Herblain, FranceRecruiting - Oncopole Claudius RegaudToulouse, FranceRecruiting - Humanitas San Pio XMilan, ItalyRecruiting - Istituto Europeo di OncologiaMilan, ItalyRecruiting - Shizuoka Cancer CenterShizuoka, JapanRecruiting - National Cancer Center HospitalTokyo, JapanRecruiting - Cancer Institute Hospital of JFCRTokyo, JapanRecruiting - National Cancer CenterGoyang-si Gyeonggi-do, South KoreaRecruiting - Hospital Universitario Vall d'HebronBarcelona, SpainRecruiting - Hospital Universitario 12 de OctubreMadrid, SpainRecruiting - Hospital Clinico Universitario de ValenciaValencia, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/482318) ### Other registry identifiers (2) - 2024-511238-11-00 - J5E-OX-JZXA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06400472) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Itraconazole](https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (9) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) Primary condition - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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