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Clinical Trial Summary

This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).


Clinical Trial Description

This study is a two-part, multicenter, open-label, multiple-dose, first-in-human study of the antibody-drug conjugate (ADC) DS-6157a given as a single agent to participants with gastrointestinal stromal tumor (GIST). This study will include 2 parts: 1. Dose Escalation (Part 1) 2. Dose Expansion (Part 2) Dose Escalation: Participants with histopathologically documented advanced GIST not amenable to curative therapy may be included in which the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of DS-6157a monotherapy will be determined. Dose Expansion: Once the RDE(s) is established for DS-6157a (Part 1), enrollment in Dose Expansion (Part 2) will commence in 2 cohorts. Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will be enrolled in Cohort 1, and participants with GIST who progressed on IM and had not received a post-IM treatment (2nd line) will be enrolled in Cohort 2. The study was terminated after Dose Escalation and the study never proceeded to the Dose Expansion part. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04276415
Study type Interventional
Source Daiichi Sankyo
Contact
Status Terminated
Phase Phase 1
Start date May 8, 2020
Completion date March 11, 2022

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