Spots Global Cancer Trial Database for A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
Official Title: A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
Study ID: NCT04419532
Interventions
Study Description
Brief Summary: The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumors for which no standard treatment is available.
Detailed Description: This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs) against DS-1055a and other antibodies.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Cincinnati Cancer Center, Cincinnati, Ohio, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
National Cancer Center Hospital, Chuo Ku, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Cancer Institute Hospital of JFCR, Koto-Ku, , Japan
Contact Details
Name: Clinical Study Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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