A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
NCT ID: NCT06238479
Last Updated: 2025-11-20
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
490 participants
INTERVENTIONAL
2024-03-05
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY4101174 (Dose-escalation, Cohort A1)
Escalating doses of LY4101174 administered intravenously (IV).
LY4101174
Intravenous
LY4101174 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.
LY4101174
Intravenous
LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5)
LY4101174 administered IV.
LY4101174
Intravenous
Interventions
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LY4101174
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 C1: triple negative breast cancer
* Cohort C2: non-small cell lung cancer
* Cohort C3: ovarian or fallopian tube cancer
* Cohort C4: cervical cancer
* Cohort C5: head and neck squamous cell carcinoma
* Prior Systemic Therapy Criteria:
* Cohort A1/C1-5: 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/C1-5: 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)
* Cohorts A2, B1, B2, C1-5: measurable disease required 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 history of corneal transplant
* Any serious unresolved toxicities from prior therapy
* Significant cardiovascular disease
* Current of history of intestinal obstruction in the previous 3 months
* Recent thromboembolic event and/or clinically significant bleeding
* 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
* Individual with active uncontrolled infection
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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AdventHealth Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UT Southwestern Medical Center
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Austin Health
Heidelberg, , Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, , Australia
Institut Jules Bordet
Anderlecht, , Belgium
Peking University First Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
Shanghai East Hospital
Shanghai, , China
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Gustave Roussy
Villejuif, , France
National Cancer Center Hospital
Chūōku, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
The Cancer Institute Hospital of JFCR
Kōtō City, , Japan
Kyoto University Hospital
Kyoto, , Japan
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
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
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Related Links
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A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Other Identifiers
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J5A-OX-JZWA
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509867-26-00
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-ENC-23001
Identifier Type: OTHER
Identifier Source: secondary_id
18836
Identifier Type: -
Identifier Source: org_study_id
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