Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-04-18 @ 5:04 AM
Study NCT ID:
NCT06465069
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014516', 'term': 'Ureteral Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031', 'timeFrame': 'Cycle 1 (21 Days)', 'description': 'Number of participants with dose-limiting toxicities (DLTs)'}, {'measure': 'Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)', 'timeFrame': 'Cycle 1 (21 Days)', 'description': 'PK: Cmin of LY4052031'}, {'measure': 'To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)', 'timeFrame': 'Cycle 1 (21 Days)', 'description': 'PK: AUC of LY4052031'}, {'measure': 'To evaluate the preliminary antitumor activity of LY4052031: Overall response rate (ORR)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1))'}, {'measure': 'To evaluate the preliminary antitumor activity of LY4052031: Duration of response (DOR)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'DOR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LY4052031: Time to response (TTR)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'TTR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LY4052031: Progression free survival (PFS)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'PFS per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LY4052031: Disease control rate (DCR)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'DCR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LY4052031: Overall survival (OS)', 'timeFrame': 'Up to Approximately 48 Months or 4 Years', 'description': 'OS per investigator assessed RECIST 1.1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'Bladder Neoplasm', 'Bladder Urothelial Carcinoma', 'Urinary Bladder Cancer', 'Urinary Tract Cancer', 'Urothelial Neoplasms', 'Renal Pelvis Cancer', 'Ureter Cancer', 'Nectin-4', 'Antibody Drug Conjugate (ADC)', 'Triple Negative Breast Cancer (TNBC)', 'Non-small Cell Lung Cancer (NSCLC)', 'Head and Neck Squamous Cell Carcinoma (HNSCC)'], 'conditions': ['Metastatic Solid Tumor', 'Recurrent Solid Tumor', 'Advanced Solid Tumor', 'Urinary Bladder Neoplasm', 'Triple Negative Breast Cancer', 'Non-small Cell Lung Cancer', 'Esophageal Cancer', 'Pancreatic Cancer', 'Ovarian Cancer', 'Cervical Cancer', 'Head and Neck Squamous Cell Carcinoma', 'Prostate Cancer', 'Renal Pelvis Cancer', 'Bladder Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/503555', 'label': 'A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n * 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\n * Cohort A2/B1/B2: urothelial carcinoma\n * 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\n* Prior Systemic Therapy Criteria:\n\n * 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\n * 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.\n* Prior enfortumab vedotin specific requirements:\n\n * Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required\n * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting\n * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.\n* Measurability of disease\n\n * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n * 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\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and/or clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis/interstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention"}, 'identificationModule': {'nctId': 'NCT06465069', 'acronym': 'NEXUS-01', 'briefTitle': 'A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '18882'}, 'secondaryIdInfos': [{'id': '2024-512927-36-00', 'type': 'CTIS'}, {'id': 'J5I-OX-JZYA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'LOXO-LNC-24001', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4052031 (Dose-escalation, Cohort A1)', 'description': 'Escalating doses of LY4052031 administered intravenously (IV).', 'interventionNames': ['Drug: LY4052031']}, {'type': 'EXPERIMENTAL', 'label': 'LY4052031 (Dose-optimization, Cohort A2)', 'description': 'Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.', 'interventionNames': ['Drug: LY4052031']}, {'type': 'EXPERIMENTAL', 'label': 'LY4052031 (Dose-expansion, Cohort B1, B2, C1)', 'description': 'LY4052031 administered IV.', 'interventionNames': ['Drug: LY4052031']}], 'interventions': [{'name': 'LY4052031', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['LY4052031 (Dose-escalation, Cohort A1)', 'LY4052031 (Dose-expansion, Cohort B1, B2, C1)', 'LY4052031 (Dose-optimization, Cohort A2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-0269', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at HealthOne', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists and Research Institute', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Chicago Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START Midwest Cancer and Hematology Centers of W Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029-6574', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3729', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030-4000', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics (START)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Utah - Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84119', 'city': 'West Valley City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START Mountain Region', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': '2010', 'city': 'Darlinghurst', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '6009', 'city': 'Nedlands', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Gustave Roussy (Igr)', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '277-8577', 'city': 'Kashiwa, Chiba', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'zip': '135-8550', 'city': 'Kōtō City', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 32.77856, 'lon': 130.74537}}, {'zip': '464-8681', 'city': 'Nagoya', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '8908', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Catalan Institute of Oncology Duran i Reynals Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Madrid Norte Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'EC1A 7BE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}