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New treatment option for Brain Cancer
Official title Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
ClinicalTrials.gov ID: NCT06058988
What this study is testing
What is Trastuzumab deruxtecan?
Trastuzumab deruxtecan is an investigational medicine, being studied as a potential treatment for brain cancer.
Also referred to as T-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out how much tratuzumab deruxtecan (T-DXd) can penetrate the tumor when injected into the body, and whether T-DXd may be an effective treatment for brain cancers that express the HER2 protein.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy
- Pathologically-documented glioblastoma; or
- Metastatic cancer that: o Has a history of Her2 expression or activating Her2-mutation
- Her2+ defined as 3+ on IHC
- Her2-low defined as IHC1+ or 2+ and ISH- according to ASCO-CAP 2018 Her2 testing guidelines52
You likely can't join if
- Contraindication or history of allergic reaction to T-DXd
- Significant comorbidities as per investigator evaluation
- Inability to comply with protocol and/or unwilling or not available for follow up assessments or any condition which in the investigator's opinion...
- Ferrous or other contraindication to MR imaging
- History of myocardial infarction within 6 months before enrollment
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
See the full eligibility criteria
Who can join
- Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy
- Pathologically-documented glioblastoma; or
- Metastatic cancer that: o Has a history of Her2 expression or activating Her2-mutation
- Her2+ defined as 3+ on IHC
- Her2-low defined as IHC1+ or 2+ and ISH- according to ASCO-CAP 2018 Her2 testing guidelines52
- Her2 mutations must be described to be activating, occur at a known hotspot (e.g. exon 20 insertions, S310, G660, R678, L755, D769, L777), or involve the transmembrane, juxtamembrane or tyrosine kinase domains
- Other untreated brain tumors (and prior radiation, including whole-brain and/or stereotactic radiation) are allowed
- Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy
- Prior treatments:
- Cohort A: Brain parenchymal metastases in patients with Her2-expressing/ERBB2- activating-mutant cancer with no prior T-DXd exposure (T-DXd naïve)
- Cohort B: Brain parenchymal metastases in patients with Her2-expressing/ERBB2- activating-mutant cancer with prior T-DXd exposure
- Cohort C: Recurrent glioblastoma
- For all cohorts: no limit on prior CNS radiation or systemic therapy, including Her2- targeting antibody therapy (including trastuzumab, pertuzumab, trastuzumab emtansine)
- KPS ≥ 60 Or ECOG \< 2
- Life expectancy \>12 weeks
- Left ventricular ejection fraction ≥50%
- Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):
- Absolute neutrophil count (ANC) ≥1.5 × 103/μL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)
- Platelet count ≥10.0x104/μL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x104/μL are not eligible. (Platelet transfusion is not allowed within 1 week prior...
- Hemoglobin ≥ 8.0 g/dL. Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible (\> 8 g/dL in gastric cancer / gastroesophageal cancer indications)...
- Serum albumin ≥ 2.5 g/dL
- Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (\<5x ULN in participants with liver metastases)
- Total bilirubin ≤1.5 × ULN) if no liver metastases or \<3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.0xULN unless on medication known to reversibly alter INR and/or aPTT
- Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative...
- Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy). Women will be considered post-menopausal if...
- Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 from the time of screening and...
- Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose ofT-DXd. Complete heterosexual...
- Female people must not donate, or retrieve for their own use, ova from the time of enrollment through at least 7 months after the final study drug administration. Preservation of ova may be considered prior to...
- Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator. Table 1: Highly effective methods of...
- Total heterosexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)
- Vasectomised sexual partner (if partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)
- Bilateral tubal occlusion
- Intrauterine device (provided coils are copper banded) Hormonal Methods
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (noting relevant contraindications in ER+ breast cancer, and risk of DVT in other cancers)
- oral
- intravaginal
- transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation
- oral
- injectable
- implantable
- Intrauterine hormone-releasing system (IUS)
What rules you out
- Contraindication or history of allergic reaction to T-DXd
- Significant comorbidities as per investigator evaluation
- Inability to comply with protocol and/or unwilling or not available for follow up assessments or any condition which in the investigator's opinion makes the patient unsuitable for study participation
- Ferrous or other contraindication to MR imaging
- History of myocardial infarction within 6 months before enrollment
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
- Corrected QT interval (QTc) prolongation to \>470 ms (females) or \>450 ms (male) based on12-lead electrocardiogram (ECG)
- people with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI
- History of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis can not be ruled out by baseline chest CT at Screening.
- Lung criteria:
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within three months of the study enrollment, severe asthma, severe...
- Any autoimmune, connective tissue or inflammatory disorders (e.g. Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
- Prior pneumonectomy (complete)
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction...
- Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if...
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: people may be enrolled with chronic, stable Grade 2 toxicities...
- Chemotherapy-induced neuropathy
- Fatigue
- Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include: i. Hypothyroidism/hyperthyroidism ii. Type 1 diabetes iii. Hyperglycemia iv. Adrenal insufficiency v. Adrenalitis vi...
- Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged...
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Pregnant or breastfeeding female patients, or patients who are planning to become pregnant.
- Patients with substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation...
- Multiple primary malignancies within 3 years, with the exception of:
- adequately resected non-melanoma skin cancer
- carcinoma in situ of the cervix
- Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider
- curatively treated in-situ disease
- other solid tumors curatively treated
- contralateral breast cancer [patients with metastatic breast cancer].
- A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.