A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
DS-1055a: Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period. Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions
Study 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.
Eligibility
Primary outcome measure(s)
- Number of participants with dose-limiting toxicities — 21 days of Cycle 1
A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) that occurs during the DLT evaluation period (21 days), excluding toxicities clearly related to disease progression or intercurrent illness or to concomitant medications or to concomitant procedures and is Grade 3 or above according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0, with certain specified exceptions. - Number of participants with adverse events — Baseline up to approximately 3 years
Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | |
| Princess Margaret Cancer Center | Toronto | Ontario | |
| National Cancer Center Hospital | Chūōku | Japan | |
| National Cancer Center Hospital East | Kashiwa | Japan | |
| Cancer Institute Hospital of JFCR | Kōtoku | Japan |
More Daiichi Sankyo trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04419532 on ClinicalTrials.gov ↗ ← All trials in the USA