Independent directory Public ClinicalTrials.gov records United States
Clinical Trials Finder
Objective public record navigation
ClinicalTrials.gov record
Recruiting Phase 1 Interventional

Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

ClinicalTrials.gov ID: NCT05372614

Public ClinicalTrials.gov record NCT05372614. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search
ClinicalTrials.gov public records Last synced Sep 10, 2026, 6:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination With Neratinib in Solid Tumors With HER2 Alterations

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene.

Study identification

NCT ID
NCT05372614
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Enrollment
58 participants

Conditions and interventions

Interventions

Procedure · Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 4, 2022
Primary completion
Jul 16, 2028
Completion
Jul 16, 2028
Last update posted
Sep 3, 2026

2022 – 2028

United States locations

U.S. sites
18
U.S. states
10
U.S. cities
16
Facility City State ZIP Site status
City of Hope Comprehensive Cancer Center Duarte California 91010 Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California 92612 Recruiting
City of Hope at Irvine Lennar Irvine California 92618 Recruiting
City of Hope Antelope Valley Lancaster California 93534 Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California 92868 Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California 95817 Recruiting
City of Hope South Pasadena South Pasadena California 91030 Recruiting
City of Hope Upland Upland California 91786 Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida 32610 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 Recruiting
UT MD Anderson Cancer Center Houston Texas 77030 Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison Wisconsin 53718 Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05372614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2026 · Synced Sep 10, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05372614 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →