> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly4175408-in-participants-with-advanced-cancer-e3f93834-229b-4651-94e5-97cd59381481 > Record changed: 2026-10-13 # A Study of LY4175408 in Participants With Advanced Cancer NCT07046923 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) Start date 2025-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Title and summary **Summary** The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Short title** A Study of LY4175408 in Participants With Advanced Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Official title** A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Dates **Completion date** 2030-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **First posted** 2025-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Registry last updated** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Primary completion date** 2030-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Start date** 2025-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Identifiers **Registry ID** NCT07046923 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **ClinicalTrials.gov ID** NCT07046923 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Outcomes ### Primary outcomes 1. Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408 Timeframe: 1 Cycle (21 days) 2. Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) Timeframe: Baseline up to approximately 4 years Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) ### Secondary outcomes 1. Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload) Timeframe: First 4 cycles (84 days) 2. Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload) Timeframe: First 4 cycles (84 days) 3. Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR Timeframe: Baseline up to approximately 4 years Per investigator assessed RECIST 1.1 4. Phase 1a and 1b-Time to Response (TTR) Timeframe: Baseline up to approximately 4 years Per investigator assessed RECIST 1.1 5. Phase 1a and 1b-Progression-free Survival (PFS) Timeframe: Baseline up to approximately 4 years Per investigator assessed RECIST 1.1 6. Phase 1a and 1b-Disease Control Rate (DCR) Timeframe: Baseline up to approximately 4 years Per investigator assessed RECIST 1.1 7. Phase 1a and 1b-Duration of Response (DOR) Timeframe: Baseline up to approximately 4 years Per investigator assessed RECIST 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Have one of the following advanced or metastatic solid tumor cancers: - Non-small cell lung cancer (NSCLC) - Small cell lung cancer (SCLC) - Endometrial cancer - Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines). - Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. - Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1. - For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B/C): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Cohorts B1/B2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion ### Exclusion criteria - Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2. - Any serious unresolved toxicities from prior therapy. - Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases. - Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. - 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 the trial or within 30 days of the last dose of trial intervention. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Sites - Stanford Medicine Cancer CenterStanford, United StatesRecruiting - Florida Cancer Specialists - Lake Nona - Sarah Cannon Research InstituteOrlando, United StatesRecruiting - Florida Cancer Specialists - SarasotaSarasota, United StatesRecruiting - The University of Chicago Medical Center (UCMC)Chicago, United StatesRecruiting - Community Health NetworkIndianapolis, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Washington UniversitySt Louis, United StatesRecruiting - John Theurer Cancer Center At Hackensack UMCHackensack, United StatesRecruiting - Columbia UniversityNew 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 - Sarah Cannon Research InstituteNashville, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - West China Hospital, Sichuan UniversityChengdu, ChinaNot yet recruiting - Shanghai East Hospital, Tongji UniversityShanghai, ChinaNot yet recruiting - Tongji Hospital - Tongji Medical College of HUSTWuhan, ChinaNot yet recruiting - Centre Leon BerardLyon, FranceRecruiting - Institut Gustave RoussyVillejuif, FranceRecruiting - Kyoto University HospitalKyoto, JapanRecruiting - National Cancer Center HospitalTokyo, JapanRecruiting - Cancer Institute Hospital of JFCRTokyo, JapanRecruiting - Severance Hospital, Yonsei University Health SystemSeoul, South KoreaRecruiting - Samsung Medical CenterSeoul, South KoreaRecruiting And 2 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/624057) ### Other registry identifiers (3) - 2025 - 2025-521916-20-00 - J6D-MC-JSDA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07046923) ## Related records ### Drugs (3) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.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 (4) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition - [Small cell lung carcinoma](https://trialight.com/data/condition/small-cell-lung-carcinoma-505ad14d-ce79-5398-b171-f724c32e1b4e.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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