NCT03451162

Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer

A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-Positive Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	DHES0815A	DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2018-04-17
• Primary completion: 2021-07-16
• Completion: 2021-07-16
• First posted: 2018-03-01
• Last updated: 2024-08-05
• Results posted: 2024-08-05

Locations

5 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study