NCT03368196

DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein

Phase 1, Multicenter, Open-label Study of DS-8201a to Assess Safety and Pharmacokinetics in Subjects With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate. The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

Detailed description

The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8 months. The screening period is 28 days and each cycle of treatment is 21 days. The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug.

Conditions

• Adenocarcinoma, Gastric
• Neoplasm, Breast

Interventions

Type	Name	Description
DRUG	DS-8201a	An antibody drug conjugate

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-09-14
• Completion: 2022-09-28
• First posted: 2017-12-11
• Last updated: 2022-11-03
• Results posted: 2021-06-14

Locations

2 sites across 1 country: Taiwan