TRIAL DETAIL

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

Drug:
Trial Name:
DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
1
Start Date 05/07/2020
Age of Trial (yrs) .3
Treatment Phase:
Gleevec-resistant
Drug Category:
TOPO-1 inhibitor
Strategy:
Interfere with DNA replication
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
DS6157-A-U101
Sponsor:
Daiichi Sankyo, Inc.
Patient Contact:
Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 (for Asia sites) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Intravenous
Trial Notes:
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.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
Chiba
277-8577
Japan
3322 West End Avenue
Nashville
TN
37203
USA