> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly4052031-in-participants-with-advanced-or-d3c1c2d7-f597-4d65-af17-9a7a48be87af > Record changed: 2026-11-04 # A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors NCT06465069 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) Participants 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) Start date 2024-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) Number of sites 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Title and summary **Summary** The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. 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/NCT06465069) **Acronym** NEXUS-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Short title** A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Official title** A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Dates **Completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **First posted** 2024-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Registry last updated** 2026-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Primary completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Start date** 2024-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Size and sites **Participants** 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Planned participants** 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Number of sites** 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Identifiers **Registry ID** NCT06465069 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **ClinicalTrials.gov ID** NCT06465069 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Outcomes ### Primary outcomes 1. Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 Timeframe: Cycle 1 (21 Days) Number of participants with dose-limiting toxicities (DLTs) 2. Phase 1b: To assess the antitumor activity of LY4052031 as monotherapy or in combination with pembrolizumab: 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) ### Secondary outcomes 1. To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin) Timeframe: Cycle 1 (21 Days) PK: Cmin of LY4052031 2. To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC) Timeframe: Cycle 1 (21 Days) PK: AUC of LY4052031 3. To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: 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)) 4. To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Duration of response (DOR) Timeframe: Up to Approximately 48 Months or 4 Years DOR per investigator assessed RECIST 1.1 5. To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Time to response (TTR) Timeframe: Up to Approximately 48 Months or 4 Years TTR per investigator assessed RECIST 1.1 6. To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Progression free survival (PFS) Timeframe: Up to Approximately 48 Months or 4 Years PFS per investigator assessed RECIST 1.1 7. To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Disease control rate (DCR) Timeframe: Up to Approximately 48 Months or 4 Years DCR per investigator assessed RECIST 1.1 8. To evaluate the preliminary antitumor activity of LY4052031 monotherapy or in combination with pembrolizumab: Overall survival (OS) Timeframe: Up to Approximately 48 Months or 4 Years OS per investigator assessed RECIST 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## 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: - Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer - Cohort A2/B/D: urothelial carcinoma - Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer - Prior Systemic Therapy Criteria: - Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies - Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies. - Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer. - Prior enfortumab vedotin specific requirements: - Cohorts A1/A2/C/D: prior treatment with enfortumab vedotin is allowed, but not required - Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting - Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting. - Measurability of disease - Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) - Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1 - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations ### Exclusion criteria - Individual with known or suspected uncontrolled CNS metastases - Individual with uncontrolled hypercalcemia - Individual with uncontrolled diabetes - Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant - Any serious unresolved toxicities from prior therapy - Significant cardiovascular disease - Recent thromboembolic event and/or clinically significant bleeding disorder - Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms - History of pneumonitis/interstitial lung disease - History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation - 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/NCT06465069) ## Sites - City of Hope National Medical CenterDuarte, United StatesRecruiting - University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, United StatesRecruiting - UCLA Department of Medicine-Hematology/OncologyLos Angeles, United StatesRecruiting - Sarah Cannon Research Institute at HealthOneDenver, United StatesRecruiting - Florida Cancer Specialists and Research InstituteSt. Petersburg, United StatesCompleted - Emory UniversityAtlanta, United StatesRecruiting - University of Chicago HospitalChicago, United StatesRecruiting - IU Simon Cancer CenterIndianapolis, United StatesNot yet recruiting - Massachusetts General HospitalBoston, United StatesRecruiting - START Midwest Cancer and Hematology Centers of W MichiganGrand Rapids, United StatesRecruiting - Washington University School of Medicine in St. LouisSt Louis, United StatesRecruiting - NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)New York, United StatesRecruiting - Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting - Columbia University Irving Medical CenterNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - University Hospitals Cleveland Medical CenterCleveland, United StatesRecruiting - Sarah Cannon Research InstituteNashville, United StatesRecruiting - Tennessee Oncology PLLCNashville, United StatesNot yet recruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - South Texas Accelerated Research Therapeutics (START)San Antonio, United StatesRecruiting - University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting - St Vincent's HospitalDarlinghurst, AustraliaRecruiting - Linear Clinical ResearchNedlands, AustraliaRecruiting - Beijing Cancer hospitalBeijing, ChinaRecruiting And 14 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/503555) ### Other registry identifiers (2) - 2024-512927-36-00 - J5I-OX-JZYA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06465069) ## Related records ### Drugs (1) - [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 (15) - [Benign urinary system neoplasm](https://trialight.com/data/condition/benign-urinary-system-neoplasm-b4be857f-35a7-5372-b076-10582d0bd795.md) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) - [Ureter cancer](https://trialight.com/data/condition/ureter-cancer-415401fb-f389-5125-9d3b-c3f822888799.md) - [Urinary bladder neoplasm](https://trialight.com/data/condition/urinary-bladder-neoplasm-269fb796-5527-5895-bad6-63dc153c3401.md) - [Uterine cervix neoplasm](https://trialight.com/data/condition/uterine-cervix-neoplasm-bc230d08-bbe4-54a9-8c15-8241ad6cb861.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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