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NCT03451162 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03451162 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 14 participants.
The verdict
NCT03451162, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
Interventions
- DRUG DHES0815A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2021-07-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03451162
The ClinicalTrials.gov registry entry for NCT03451162 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DHES0815A is the first listed.
NCT03451162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03451162 about?
NCT03451162 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer". 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 ...
What is the current status of trial NCT03451162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2018-04-17. Estimated completion is 2021-07-16.
What interventions are being tested in trial NCT03451162?
The interventions under investigation include: DHES0815A (DRUG).
Who is sponsoring clinical trial NCT03451162?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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