CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
DHES0815Adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03451162
NCT03451162Phase 1Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Mar 1, 2018·Updated Aug 5, 2024

In Brief

A Phase 1 clinical trial evaluating DHES0815A for Breast Cancer. Completed, enrolled 14 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesSouth Korea, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 1, 2018
Enrollment StartApr 17, 2018
Primary CompletionJul 16, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.3 years ago

Interventions

DHES0815Adrug

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