Last updated on June 2019

First-in-human Study of DS-1062a for Advanced Solid Tumors

Brief description of study

This study is one single group of participants with NSCLC who have not been cured by other treatments. It is the first time the drug has been used in humans, and will be in two parts.

The primary purpose of the parts are:

  • Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a
  • Dose Expansion: To investigate the safety and tolerability of DS-1062a

This study is expected to last approximately 2.5 years from the time the first subject is enrolled to the time the last subject is off the study.

The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:

  • they withdraw
  • their disease gets worse
  • they experience unacceptable side effects.

Detailed Study Description

The dosage strength will change during the study but all participants will receive the same study drug. So the study is not a true 2-arm study, it is a 2-part study.

In both parts, subjects with pathologically documented unresectable advanced NSCLC who have been refractory to or relapsed from standard treatment or for which no standard treatment is available, will be enrolled. Additional solid tumors might be evaluated, if the study treatment demonstrates acceptable safety, tolerability and efficacy in NSCLC patients. After the primary analysis, the main (registered) study will be considered complete, but data will be collected from participants who continue receiving study drug.

Clinical Study Identifier: NCT03401385

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Virginia Cancer Specialists

Fairfax, VA United States
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Recruitment Status: Open

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