Actively Recruiting
5G-EMERALD: A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-04-25
12
Participants Needed
2
Research Sites
52 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
Researchers are evaluating the safety and tolerability of amivantamab, an investigational drug, in patients with high grade malignant brain tumours such as glioblastoma. This Phase 1b trial focuses on a biomarker-defined group of patients whose tumours show EGFR amplification. The study aims to determine the preliminary anti-tumour activity of amivantamab administered at the recommended Phase 2 dose, with decisions guided by adaptive trial design and safety review committees. Amivantamab will be given by intravenous infusion weekly for the first 4 weeks, then every 2 weeks thereafter until the disease progresses or unacceptable side effects occur. The initial dose is split over two days, with subsequent doses given over 2 to 5 hours initially and shorter infusions if well tolerated. This Phase 1b biomarker arm will enroll 12 patients with relapsed glioblastoma to assess treatment effects. Participants will undergo regular monitoring including whole genome and transcriptome data collection as part of the Minderoo Precision Brain Tumour Programme. Safety and tumour response will be closely assessed through clinical evaluations and imaging over an 18-month period. The main outcomes measured are safety, tolerability, and preliminary anti-tumour activity, with additional analysis of molecular markers related to treatment response.
CONDITIONS
Brief Title
5G-EMERALD: Amivantamab in Malignant Brain Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed advanced WHO Stage IV glioblastoma or Grade 4 astrocytoma as per WHO 2016/2021 classifications
- Consent to the Minderoo Precision Brain Tumour Programme with available whole genome and transcriptome data
- Eligible at first relapse after optimal surgery and Stupp based chemo-radiotherapy with measurable or evaluable disease
- Eligible for front line minimal residual disease cohort after similar treatment
- Age 16 years or older
- Life expectancy of at least 12 weeks
- WHO performance status 0-1
- Neurologically stable without recent worsening symptoms or steroid dose increase
- Able to give written informed consent and cooperate with treatment and follow-up
- Blood counts and biochemical markers within specified ranges before first dose
- Negative pregnancy test for females of reproductive potential and agreement to pregnancy testing during the study
- Agreement to use contraception or abstinence during and 6 months after study treatment
- Agreement not to donate eggs or sperm during study and for 6 months after treatment
- Willingness and ability to follow lifestyle restrictions in the protocol
You will not qualify if you...
- Treatment with cytotoxic chemotherapy, bevacizumab, or investigational drugs within specified intervals before first dose
- Prior immune checkpoint inhibitor, vaccine, or EGFR-targeting therapy
- Ongoing Grade 2 or higher toxicities from previous conditions or treatments
- Presence of carcinomatous meningitis, leptomeningeal spread, or tumour spread to brain stem or spinal cord
- Recent intratumoural or peritumoural haemorrhage not stable on MRI
- History of significant bleeding disorders or recent gastrointestinal bleeding
- Active cardiovascular disease including recent thrombotic events, uncontrolled hypertension, or heart failure
- History of malabsorption or inflammatory bowel diseases
- Urine protein over specified limits
- Significant lung diseases including pneumonitis or active infections
- Positive hepatitis B surface antigen or uncontrolled hepatitis C
- HIV infection with certain risk factors or not on stable antiretroviral therapy
- Uncontrolled illnesses including diabetes, active infections, bleeding, or unstable psychiatric or ophthalmologic conditions
- Steroid requirement above specified dose for neurological symptoms
- Recent live vaccine within 30 days before study therapy
- Concurrent or prior malignancy excluding certain cured cancers
- Participation in another interventional clinical trial
- Recent major or minor surgery without full recovery
- Recent palliative radiotherapy
- Any other condition making the patient unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable toxicity
Participants receive amivantamab intravenously weekly for the first 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity.
Weekly visits for the first 4 weeks, then visits every 2 weeks
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
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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