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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

Must not have

History of symptomatic congestive heart failure

Prior pneumonectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had symptoms of heart failure.

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I have had a lung removed.

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I am able to follow the study plan and attend all check-ups.

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I had a heart attack less than 6 months ago.

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I have a history of lung inflammation not caused by infection.

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I do not have an infection needing IV drugs.

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I still have side effects from past cancer treatments.

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I have serious lung-related health issues.

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I need treatment for fluid buildup in my chest, abdomen, or around my heart.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Hypokalaemia

16%

Neutrophil Count Decreased

16%

Aspartate Aminotransferase Increased

15%

Asthenia

14%

Abdominal Pain

11%

Cough

11%

Pyrexia

11%

White Blood Cell Count Decreased

11%

Blood Alkaline Phosphatase Increased

10%

Epistaxis

10%

Hypoalbuminaemia

10%

Neutropenia

10%

Gastrooesophageal Reflux Disease

10%

Alanine Aminotransferase Increased

Dyspnoea

Back Pain

Headache

Hypotension

Hyponatraemia

Dizziness

Pneumonitis

Ascites

Urinary Retention

Abdominal Pain Upper

Dysphagia

Covid-19

Insomnia

Thrombocytopenia

Weight Increased

Blood Bilirubin Increased

Interstitial Lung Disease

Acute Kidney Injury

Device Related Infection

Hypophosphataemia

Depression

Flatulence

Mucosal Inflammation

Blood Creatinine Increased

Urinary Tract Infection

Oedema Peripheral

Pneumonia

Disease Progression

Malignant Neoplasm Progression

Hyperpyrexia

Colitis

Haematemesis

Wound Infection

Bacterial Sepsis

Staphylococcal Infection

Covid-19 Pneumonia

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2021

Completed Phase 2

~800

0 / 13Eligibility criteria met