A Study of LY4175408 in Participants With Advanced Cancer
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Endometrial Neoplasms
Neoplasm Metastasis
Triple Negative Breast Cancer
Спонсор: Eli Lilly and Company
Налично на:
БГ
Обобщение
The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.
Кой може да участва
Inclusion Criteria:
* Have one of the following advanced or metastatic solid tumor cancers:
* Non-small cell lung cancer (NSCLC)
* Small cell lung cancer (SCLC)
* Endometrial cancer
* Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).
* Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator; OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
* For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria:
* Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted).
* Any serious unresolved toxicities from prior therapy.
* Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.
* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
* Significant cardiovascular disease.
* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds (ms)
* History of pneumonitis/interstitial lung disease.
* Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.
Интервенции
LY4175408
DRUG
Места на провеждане
25
Китай (1)
Shanghai East Hospital, Tongji University
Shanghai
NOT_YET_RECRUITING
Франция (2)
Centre Leon Berard
Lyon
Institut Gustave Roussy
Villejuif
Япония (3)
Kyoto University Hospital
Kyoto
National Cancer Center Hospital
Tokyo
Cancer Institute Hospital of JFCR
Tokyo
Южна Корея (2)
Severance Hospital, Yonsei University Health System
Seoul
Samsung Medical Center
Seoul
Испания (2)
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario 12 de Octubre
Madrid
САЩ (15)
Massachusetts General Hospital
Boston , Massachusetts
The University of Chicago Medical Center (UCMC)
Chicago , Illinois
The Ohio State University (OSU) Wexner Medical Center
Columbus , Ohio
NEXT Virginia
Fairfax , Virginia
John Theurer Cancer Center At Hackensack UMC
Hackensack , New Jersey
MD Anderson Cancer Center
Houston , Texas
Community Health Network
Indianapolis , Indiana
NOT_YET_RECRUITING
Sarah Cannon Research Institute
Nashville , Tennessee
Columbia University
New York , New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York , New York
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute