NCT02564900

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	DS-8201a (DP1)	DS-8201a to be administered via intravenous (IV) dose. DS-8201a (DP1) was used for the Dose Escalation phase and for Dose expansion Parts 2a, 2b, 2c, and 2d.
DRUG	DS-8201a (DP2)	DS-8201a is to be administered via intravenous (IV) dose. DS-8201a (DP2) was used only used for Dose Expansion Part 2e.
DRUG	DS-8201a (DP)	DS-8201a (DP) is to be administered via intravenous (IV) dose.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-02-01
• Completion: 2023-12-22
• First posted: 2015-10-01
• Last updated: 2024-01-22
• Results posted: 2021-06-23

Locations

14 sites across 2 countries: United States, Japan