DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)

DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal Stromal Tumor

Active, not recruiting

1

Start Date 05/07/2020

Age of Trial (yrs) 4.5

Gleevec-resistant

TOPO-1 inhibitor

Interfere with DNA replication

Specifically GIST and only GIST

DS6157-A-U101

Daiichi Sankyo, Inc.

Contact: Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com Contact: (for Asia sites) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Intravenous

Detailed 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:

Dose Escalation (Part 1)
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 or who are intolerant to IM (2nd line) will be enrolled in Cohort 2.