Phase
Condition
Non-small Cell Lung Cancer
Vaginal Cancer
Head And Neck Cancer
Treatment
LY4101174
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have one of the following solid tumor cancers:
Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small celllung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervicalcancer (squamous cell carcinoma), head and neck squamous cell carcinoma orprostate 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 theparticipant was deemed to be an appropriate candidate by the treatinginvestigator; OR there is no standard therapy available for the disease. Thereis no restriction on number of prior therapies
Cohort A2/B1/B2: Individual must have received at least one prior regimen inthe advanced or metastatic setting. There is no restriction on number of priortherapies.
Prior enfortumab vedotin specific requirements:
Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but notrequired
Cohort B1: individual must be enfortumab vedotin naive in theadvanced/metastatic setting
Cohort B2: individual must have received enfortumab vedotin in themetastatic/advanced setting.
Measurability of disease
Cohort A1: measurable or non-measurable disease as defined by ResponseEvaluation 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 biopsyif allowed per country specific regulations
Exclusion
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 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 or 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 orwithin 30 days of last dose of study intervention
Individual with active uncontrolled infection
Study Design
Study Description
Connect with a study center
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia 5037
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Institut Jules Bordet
Brussels, 1070
BelgiumActive - Recruiting
The Cancer Institute Hospital of JFCR
Koto, Tokyo 135-8550
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Koto City, Tokyo 135-8550
JapanActive - Recruiting
National Cancer Center Hospital
Chuo Ku, 104-0045
JapanActive - Recruiting
Kyoto University Hospital
Kyoto, 606-8507
JapanActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
MD Anderson Cancer Center
Madrid, 28033
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Advent Health Orlando
Orlando, Florida 32804
United StatesActive - Recruiting
Advent Health Orlando Hospital
Orlando, Florida 32804
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
New York University Medical Center
New York, New York 10016
United StatesSite Not Available
University of North Carolina Medical Center
Chapel Hill, North Carolina 27599-7305
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390-8884
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 78229-3307
United StatesActive - Recruiting
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