A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
NCT ID: NCT06465069
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
420 participants
INTERVENTIONAL
2024-07-01
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY4052031 (Dose-escalation, Cohort A1)
Escalating doses of LY4052031 administered intravenously (IV).
LY4052031
Intravenous
LY4052031 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
LY4052031
Intravenous
LY4052031 (Dose-expansion, Cohort B1, B2, C1)
LY4052031 administered IV.
LY4052031
Intravenous
Interventions
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LY4052031
Intravenous
Eligibility Criteria
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Inclusion Criteria
* 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/B1/B2: 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.
* Prior enfortumab vedotin specific requirements:
* Cohorts A1/A2/C: 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 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 when receiving enfortumab vedotin
* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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City of Hope National Medical Center
Duarte, California, United States
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, United States
University of Chicago Hospital
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest Cancer and Hematology Centers of W Michigan
Grand Rapids, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
START Mountain Region
West Valley City, Utah, United States
St Vincent's Hospital
Darlinghurst, , Australia
Linear Clinical Research
Nedlands, , Australia
Institut Gustave Roussy (Igr)
Villejuif, , France
National Cancer Center Hospital East
Kashiwa, Chiba, , Japan
The Cancer Institute Hospital of JFCR
Kōtō City, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Asan Medical Center
Seoul, , South Korea
Catalan Institute of Oncology Duran i Reynals Hospital
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Madrid Norte Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
St Bartholomew's Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Related Links
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A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Other Identifiers
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2024-512927-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
J5I-OX-JZYA
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-LNC-24001
Identifier Type: OTHER
Identifier Source: secondary_id
18882
Identifier Type: -
Identifier Source: org_study_id