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Kinase Inhibitor

Trastuzumab Deruxtecan + Neratinib for Cancer

Phase 1
Recruiting
Led By Andrew A Davis
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 must have at least one lesion suitable for biopsy without significant risk to the patient
Patients who had clinically significant side effects from prior cancer therapy must have recovered to grade 1 or below
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of combining neratinib with trastuzumab deruxtecan to treat patients with metastatic or unresectable solid tumors that have a change in the HER2 gene.

Who is the study for?
Adults with advanced solid tumors that can't be removed by surgery or have spread, and have changes in the HER2 gene. They must not have had previous treatments with neratinib or DS-8201a, should not be pregnant or breastfeeding, and need to agree to use contraception. People with certain heart conditions, severe lung issues, recent major surgeries or radiation therapy are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of two anti-cancer drugs: Trastuzumab Deruxtecan and Neratinib Maleate for safety and optimal dosing against cancers with HER2 gene alterations. It includes various assessments like scans and biopsies to monitor effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation of organs (like lungs), digestive problems including diarrhea, blood disorders which could affect cell counts, fatigue from treatment-related anemia, possible heart complications due to drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be safely biopsied.
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I have recovered from serious side effects of my previous cancer treatment.
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I am 18 years old or older.
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I have chronic hepatitis B but my viral load is undetectable.
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My heart condition allows me to perform daily activities with slight limitations.
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I am HIV-positive but stable on my medication and healthy.
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My tumor is HER2 positive based on specific tests.
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My kidney function is within the required range.
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I am mostly active and can carry out light work.
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My brain metastases have been treated.
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I have had at least one treatment for my cancer after it spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities
Incidence of treatment-emergent adverse events
Secondary outcome measures
DXd (MAAA-1181a) tissue concentration
Duration of response
Incidence of adverse events
+5 more
Other outcome measures
Circulating cell-free DNA
Deoxyribonucleic acid (DNA) damage
Quantitative HER2 protein
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (neratinib, trastuzumab deruxtecan)Experimental Treatment7 Interventions
Patients receive neratinib PO QD on days 1-21 (days 8-21 of cycle 1, then days 1-21 in cycles thereafter for PD study) of each cycle and 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 blood sample collection, CT scan and echocardiograpahy or MUGA scan throughout study. Additionally, patients may undergo a tissue biopsy at baseline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Trastuzumab Deruxtecan
2021
Completed Phase 3
~510
Biopsy
2014
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,317 Total Patients Enrolled
Andrew A DavisPrincipal InvestigatorYale University Cancer Center LAO
Haeseong ParkPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials

Media Library

Neratinib Maleate (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05372614 — Phase 1
Cancer Research Study Groups: Treatment (neratinib, trastuzumab deruxtecan)
Cancer Clinical Trial 2023: Neratinib Maleate Highlights & Side Effects. Trial Name: NCT05372614 — Phase 1
Neratinib Maleate (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05372614 — Phase 1

Frequently Asked Questions

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

Does this research study currently accept participants?

"The data on clinicaltrials.gov affirms that this study is still open to enrolment and has been since June 17th 2022; with the last update occurring September 28th 2022."

Answered by AI

How many participants are being recruited for this investigation?

"Affirmative. According to information available on clinicaltrials.gov, this investigation began enrolling participants after it was posted in June of 2022 and is still recruiting today. The study requires 18 individuals from two different medical facilities for its completion."

Answered by AI

Has the Trastuzumab Deruxtecan drug been sanctioned by the U.S. Food and Drug Administration?

"Trastuzumab Deruxtecan's safety has been assessed as a 1 on the scale of 1-3 due to its position in Phase 1 trials. This indicates that there is limited information regarding both its efficacy and safety."

Answered by AI

To what end does this clinical experiment aim to accomplish?

"The primary assessment of this trial within the span of 42 days is to gauge incidence of dose-limiting toxicities. Secondary objectives include progression-free survival, as measured by RECIST v 1.1 with Kaplan Meier product limit methods, and pharmacokinetic profiles for both DS - 8201a and neratinib alongside their respective metabolites using descriptive statistics along with ANOVA & regression model analysis in order to analyse any correlations between PK biomarker levels and anti-tumor efficacy. The endpoint data will be analysed including mean values, standard deviation, median value, minimum & maximum value respectively."

Answered by AI
~3 spots leftby Jun 2024