Actively Recruiting
5G-EMERALD: Amivantamab in Malignant Brain Tumours
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-04-25
12
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
R
Royal Marsden NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study a biomarker defined arm will be opened, initially in the relapsed GMB setting, enrolling 12 patients. These patients will be treated with amivantamab monotherapy. Amivantamab will be administered intravenously (IV) weekly for the first 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. The first dose will be given as a split infusion, 350 mg IV over 4 hours on cycle 1 day 1 and 1400 mg IV over 6 hours on cycle 1 day 2. Subsequent infusions are given at a dose of 1750 mg IV over 2-5 hours in cycle 1 and between 2-3 hours from cycle 2 onwards if the first dose was well-tolerated with no significant toxicity. Progression to Phase 2 is dependent on emergent data and funding.
CONDITIONS
Official Title
5G-EMERALD: Amivantamab in Malignant Brain Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 16 years or older with histologically confirmed advanced WHO Stage IV glioblastoma or related molecular subtypes
- Consent to Minderoo Precision Brain Tumour Programme with available whole genome and transcriptome data
- First relapse after optimal surgery and Stupp-based chemoradiotherapy with measurable or evaluable disease
- Front line minimal residual disease cohort eligible after completion of optimal surgery and chemoradiotherapy
- Life expectancy of at least 12 weeks
- WHO performance status of 0-1
- Neurologically stable without recent progression or escalating systemic steroid use
- Ability to provide informed consent and cooperate with treatment and follow-up
- Adequate hematological and biochemical lab values within one week prior to first dose
- Negative pregnancy test for females with reproductive potential and agreement to pregnancy testing during study
- Agreement to use effective contraception or abstinence during study and for 6 months after last dose
- Agreement not to donate eggs or sperm during study and for 6 months after last dose
- Willingness to adhere to lifestyle restrictions specified in the protocol
You will not qualify if you...
- Treatment with cytotoxic chemotherapy within 2 weeks (6 weeks for nitrosoureas) or bevacizumab within 6 weeks prior to first dose
- Prior immune checkpoint inhibitor, vaccine, or EGFR-targeting therapy
- Ongoing grade 2 or higher toxicities from prior treatments
- Presence of carcinomatous meningitis, leptomeningeal spread, or tumor spread to brain stem or spinal cord
- Recent intratumoural or peritumoural hemorrhage on baseline MRI unless stable on consecutive scans
- History of significant bleeding disorders or recent gastrointestinal bleeding
- Active cardiovascular disease including recent thrombosis or uncontrolled hypertension
- History of malabsorption or inflammatory bowel disease
- Urine protein greater than 1g/24 hours or significant proteinuria
- Significant lung disease or history of opportunistic infections
- Positive hepatitis B surface antigen or active hepatitis C infection
- Positive HIV status with uncontrolled infection or interfering antiretroviral therapy
- Uncontrolled illnesses including active infections, bleeding disorders, or unstable ophthalmologic conditions
- Steroid use greater than 3mg dexamethasone daily unless stable for at least 5 days
- Receipt of live vaccine within 30 days prior to study treatment
- Concurrent or prior malignancy other than the study disease unless fully cured and meeting exceptions
- Participation in another interventional clinical trial during this study
- Recent major surgery or trauma within specified recovery periods
- Palliative radiotherapy within 1 week of first dose
- Any other condition judged by investigator to make the patient unsuitable for the trial
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cambridge University Hospitals
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
2
The Royal Marsden Hospital - Drug Development Unit
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
5
5G Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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