Phase
Condition
Neoplasms
Neuroblastoma
Metastatic Cancer
Treatment
DS-1055a
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has a histopathologically documented locally advanced or metastatic head and neck,gastric, esophageal cancer, non-small cell lung cancer, or melanoma. Participantswith other types of solid tumors may be eligible following discussion with theSponsor.
Has a relapsed or refractory disease that is not amenable to curative standardtherapy.
Is 18 years of age or older.
Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, withno deterioration for two weeks.
Has a measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Has adequate organ function within 7 days before enrollment.
Is able to provide written informed consent and is willing and able to comply withthe protocol.
Exclusion
Exclusion Criteria:
Has a concurrently active second malignancy, other than adequately treatednon-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participantswith history of the second malignancy have been disease-free for <3 years.
Has a history of (non-infectious) interstitial lung disease (ILD) that requiredsteroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging atscreening.
Has a history of severe pulmonary compromise or requirement of supplemental oxygenwithin 6 months before enrollment.
Has active hepatitis B or hepatitis C virus infection.
Has received prior immunotherapy with a Grade 3 or higher, or any unresolved ≥Grade 2 immune-related adverse event.
Study Design
Study Description
Connect with a study center
Princess Margaret Cancer Center
Toronto, Ontario M5G 2C1
CanadaSite Not Available
National Cancer Center Hospital
Chuo Ku, 104-0045
JapanSite Not Available
National Cancer Center Hospital East
Kashiwa, 277-8577
JapanSite Not Available
Cancer Institute Hospital of JFCR
Koto-Ku, 135-8550
JapanSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
University of Cincinnati Cancer Center
Cincinnati, Ohio 45219
United StatesSite Not Available
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