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Monoclonal Antibodies

Trastuzumab Deruxtecan for Brain Cancer

Phase 2

Recruiting

Led By Nelson Moss, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Pathologically-documented glioblastoma

KPS ≥ 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is researching if a new drug (T-DXd) can effectively treat brain cancer with HER2 protein.

Who is the study for?

This trial is for adults with brain cancer that expresses the HER2 protein, who have a life expectancy of more than 12 weeks and are scheduled for neurosurgical resection/biopsy. Participants must be over 18, not pregnant or breastfeeding, and have recovered from previous treatments. They should not have had a heart attack recently or suffer from significant illnesses that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing Trastuzumab deruxtecan (T-DXd) to see how well it penetrates brain tumors and if it's effective against certain types of brain cancers related to the HER2 protein. It will involve patients receiving T-DXd injections before their planned surgeries.See study design

What are the potential side effects?

Potential side effects include allergic reactions to T-DXd or its ingredients, lung issues like interstitial lung disease/pneumonitis, heart problems such as congestive heart failure, infections requiring IV treatment, and severe hypersensitivity reactions similar to other monoclonal antibodies.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is glioblastoma confirmed by a biopsy.

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I can care for myself but may need occasional help.

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I am 18 or older and scheduled for brain tumor surgery.

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My cancer has spread and shows HER2 activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Intraoperative plasma concentrations in brain tumors after T-DXd injections

Side effects data

From 2024 Phase 2 trial • 79 Patients • NCT04014075

65%

Nausea

44%

Vomiting

42%

Fatigue

38%

Anaemia

37%

Diarrhoea

35%

Weight Decreased

33%

Decreased Appetite

29%

Constipation

24%

Alopecia

18%

Platelet Count Decreased

16%

Aspartate Aminotransferase Increased

16%

Neutrophil Count Decreased

16%

Hypokalaemia

15%

Asthenia

14%

Abdominal Pain

11%

Pyrexia

11%

Cough

11%

White Blood Cell Count Decreased

11%

Blood Alkaline Phosphatase Increased

10%

Neutropenia

10%

Hypoalbuminaemia

10%

Epistaxis

10%

Gastrooesophageal Reflux Disease

10%

Alanine Aminotransferase Increased

Back Pain

Dyspnoea

Headache

Hyponatraemia

Hypotension

Dizziness

Urinary Retention

Ascites

Pneumonitis

Abdominal Pain Upper

Dysphagia

Covid-19

Insomnia

Thrombocytopenia

Weight Increased

Blood Bilirubin Increased

Acute Kidney Injury

Interstitial Lung Disease

Device Related Infection

Hypophosphataemia

Depression

Flatulence

Mucosal Inflammation

Blood Creatinine Increased

Urinary Tract Infection

Oedema Peripheral

Pneumonia

Disease Progression

Malignant Neoplasm Progression

Wound Infection

Colitis

Covid-19 Pneumonia

Hyperpyrexia

Staphylococcal Infection

Haematemesis

Bacterial Sepsis

Intestinal Obstruction

Animal Bite

Enteritis

Basal Ganglia Infarction

Cerebrovascular Accident

Generalised Tonic-Clonic Seizure

Pulmonary Embolism

Lymphangiosis Carcinomatosa

Tumour Haemorrhage

Bile Duct Stenosis

Hepatotoxicity

Hydronephrosis

Urinary Tract Obstruction

Exposure To Communicable Disease

Device Occlusion

Catheter Site Infection

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab Deruxtecan

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment1 Intervention

Participants with recurrent glioblastoma requiring neurosurgical resection/biopsy

Group II: Cohort BExperimental Treatment1 Intervention

Participants with Her2-expressing or solid tumors with activating ERBB2 mutations with 1 or more CNS metastases requiring neurosurgical resection/biopsy with no prior T-DXd and prior T-DXd exposure and with documented radiological CNS progression while on T-DXd, requiring neurosurgical resection/biopsy of 1 or more recurrent metastases, with continuation of T-DXd until prior to surgery

Group III: Cohort AExperimental Treatment1 Intervention

Participants with Her2-expressing or solid tumors with activating ERBB2 mutations with 1 or more CNS metastases requiring neurosurgical resection/biopsy with no prior T-DXd

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab deruxtecan

2022

Completed Phase 2

~400

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,868 Total Patients Enrolled

16 Trials studying Glioblastoma

1,255 Patients Enrolled for Glioblastoma

AstraZenecaIndustry Sponsor

4,272 Previous Clinical Trials

288,612,645 Total Patients Enrolled

14 Trials studying Glioblastoma

973 Patients Enrolled for Glioblastoma

Nelson Moss, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

93 Total Patients Enrolled

Frequently Asked Questions

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

Are there still slots available for possible participants in this research?

"Affirmative. Clinicaltrials.gov states that this investigation is in search of participants, which was initially published on September 22nd 2023 and has been recently updated. The research requires 30 people to be recruited from 1 site."

Answered by AI

How many people are actively participating in this research endeavor?

"Affirmative, the clinicaltrial.gov page reveals that this medical trial is inviting patients to participate. It was first posted on September 22nd 2023 and its most recent edit also occurred then. The study requires 30 individuals from one location."

Answered by AI