NCT04276415

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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: 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.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	DS-6157a	Administered as a single agent intravenously (IV) every 3 weeks

Timeline

• Start date: 2020-05-08
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2020-02-19
• Last updated: 2024-02-15
• Results posted: 2024-02-15

Locations

5 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study