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NCT04509596 · ClinicalTrials.gov registry record · Phase 1

DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer

A Phase 1 study of Breast Cancer Metastatic, sponsored by Dizal Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
3
Study locations

NCT04509596 is a Phase 1 study of Breast Cancer Metastatic that has completed, run by Dizal Pharmaceuticals. The registered enrollment target is 23 participants, below the 91-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT04509596, a Phase 1 study of Breast Cancer Metastatic, has completed, sponsored by Dizal Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
3
Study locations

Study Summary

DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy and in combination with trastuzumab and/or capecitabine, or in combination with T-DM1

Conditions Studied

Breast Cancer Metastatic

Interventions

  • DRUG DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C

Study Locations (3)

Other

  • Zhejiang Cancer Hospital - Hangzhou
  • Cancer Hospital, Fudan University - Shanghai

California

  • UCLA Hematology/Oncology Parkside - Santa Monica

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2020-09-21
Est. Completion 2022-07-07
Phase Phase 1

Sponsor

Dizal Pharmaceuticals

15 total trials

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What the Registry Record Tells You About NCT04509596

The ClinicalTrials.gov registry entry for NCT04509596 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target (75% lower). The listed sponsor is Dizal Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention - of which DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C is the first listed.

NCT04509596 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, California.

Frequently Asked Questions

What is clinical trial NCT04509596 about?

NCT04509596 is a clinical study titled "DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer". DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this dru...

What is the current status of trial NCT04509596?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-09-21. Estimated completion is 2022-07-07.

What conditions does trial NCT04509596 study?

This clinical trial studies the following conditions: Breast Cancer Metastatic.

What interventions are being tested in trial NCT04509596?

The interventions under investigation include: DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C (DRUG).

Who is sponsoring clinical trial NCT04509596?

This trial is sponsored by Dizal Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04509596 being conducted?

This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.