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Monoclonal Antibodies

Trastuzumab Deruxtecan for Advanced HER2 Positive Cancer

Phase 1

Recruiting

Led By Geraldine O'Sullivan Coyne

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured

Women of non-child-bearing potential are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1, prior to ds-8201a administration, at end of infusion, and at 5 hours post-infusion; at time of the cycle 1 day 7 biopsy; on day 1 of cycles 2, 3, and 4: prior to ds-8201a administration and at end of infusion

Awards & highlights

Study Summary

This trial is studying the effects of DS-8201a on patients with advanced HER2 positive cancer. DS-8201a works by binding to HER2 on the surface of tumor cells and damaging their DNA, resulting in tumor cell death.

Who is the study for?

This trial is for adults with advanced HER2 positive cancer, who have measurable or evaluable disease and are not responding to standard treatments. Participants must be willing to undergo biopsies, provide blood samples, and have a good performance status (able to carry out daily activities). They should not be pregnant or breastfeeding and must use contraception. People with recent major surgeries, certain heart conditions, uncontrolled infections or illnesses that could interfere with the study cannot join.Check my eligibility

What is being tested?

The trial is testing DS-8201a's biological effects on patients with advanced HER2 positive cancers. It involves examining how this drug affects protein levels and immune cells in tumors by analyzing biopsy samples before and after treatment. The study includes tests like echocardiography, MRI scans, CT scans, MUGA scans, biospecimen collection, and biopsies to monitor the drug's impact.See study design

What are the potential side effects?

DS-8201a may cause side effects such as damage to DNA leading to tumor cell death which can result in fatigue, nausea or other common chemotherapy-related symptoms. Specific side effects will vary from person to person based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but have been treated and cured.

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I am a woman who cannot become pregnant.

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I am 18 years old or older.

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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.

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My hepatitis B virus is under control with treatment.

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My tumor is HER2-positive, confirmed by a certified lab.

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My liver function tests are within the required range.

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I am willing to have 3 needle biopsies for research.

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I am mostly active and can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the treatment until disease progression/recurrence

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the treatment until disease progression/recurrence

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment until disease progression/recurrence for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Early topoisomerase 1 cleavable complex (Top1cc)/deoxyribonucleic acid (DNA) damage response (DDR)

Tumor immune microenvironment response

Secondary outcome measures

Serum

Incidence of adverse events

Overall response rate

Other outcome measures

Pharmacodynamic analysis

Pharmacokinetic analysis

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (trastuzumab deruxtecan)Experimental Treatment7 Interventions

Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA, CT or MRI, biopsies, and collection of blood samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Trastuzumab Deruxtecan

2021

Completed Phase 3

~510

Biopsy

2014

Completed Phase 4

~1090

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,484 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Geraldine O'Sullivan CoynePrincipal InvestigatorNational Cancer Institute LAO

4 Previous Clinical Trials

216 Total Patients Enrolled

Alice P ChenPrincipal InvestigatorNational Cancer Institute LAO

3 Previous Clinical Trials

167 Total Patients Enrolled

Media Library

Trastuzumab Deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04294628 — Phase 1

Breast Cancer Research Study Groups: Treatment (trastuzumab deruxtecan)

Breast Cancer Clinical Trial 2023: Trastuzumab Deruxtecan Highlights & Side Effects. Trial Name: NCT04294628 — Phase 1

Trastuzumab Deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294628 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently welcoming volunteers?

"According to clinicaltrials.gov, this medical trial is currently looking for participants and was first advertised on July 14th 2020 with the most recent edit taking place on November 8th 2022."

Answered by AI

Does this experimental research represent a pioneering effort?

"Trastuzumab Deruxtecan has been under examination since 2015, with the initial clinical trial sponsored by Daiichi Sankyo, Inc. This study, which studied 292 participants, granted Trastuzumab Deruxtecan its Phase 1 drug approval in due course. Nowadays there are 36 active studies concerning this medication distributed across 483 cities and 44 countries."

Answered by AI

What is the aggregate count of individuals involved in this trial?

"Affirmative. Clinicaltrials.gov data indicates that this medical trial, initially posted on July 14th 2020, is currently enrolling patients. As many as 37 volunteers from 5 different sites need to be recruited for the study."

Answered by AI

Are there any related investigations involving Trastuzumab Deruxtecan?

"Trastuzumab Deruxtecan was initially researched back in 2015 by UC Health Clinical Trials Office. Over the course of six years, 131 clinical studies have been completed and 36 active trials are being conducted at various locations including Pittsburgh, Pennsylvania."

Answered by AI

What are the potential risks associated with Trastuzumab Deruxtecan use?

"As a Phase 1 trial, the safety of Trastuzumab Deruxtecan has been assessed to be a score of 1 due to limited research on its efficacy."

Answered by AI

How many sites have been designated to conduct this experiment?

"This trial is enrolling patients from UPCI in Pittsburgh, Ohio State University Comprehensive Cancer Center in Columbus, and the National Cancer Institute Developmental Therapeutics Clinic in Bethesda. In addition, there are 5 additional sites across America taking part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer

2020. "Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294628.

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