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

Gastrointestinal Stromal Tumors Clinical Trial

Official title: Phase 1, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Subjects With Advanced Gastrointestinal Stromal Tumor

Status Terminated

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. ;

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

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