OncoMatch/Clinical Trials/NCT06632236
5G-EMERALD: Amivantamab in Malignant Brain Tumours
Is NCT06632236 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Amivantamab for malignant primary gliomas.
Treatment: Amivantamab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Allowed: IDH1 wild-type
Glioblastoma, IDH-wildtype Grade 4
Allowed: IDH1 mutation
Astrocytoma, IDH-mutant, Grade 4
Allowed: H3-3A G34 mutation
Diffuse hemispheric glioma, H3 G34 mutant Grade 4
Disease stage
Required: Stage IV, GRADE 4 (WHO CNS 2016/2021)
Excluded: Stage GRADE 2, GRADE 3
Grade: 4 (WHO)
WHO Stage IV glioblastoma (per fourth edition 2016)... fifth edition... includes: Glioblastoma, IDH-wildtype Grade 4; Astrocytoma, IDH-mutant, Grade 4; Diffuse hemispheric glioma, H3 G34 mutant Grade 4
Performance status
WHO 0–1
Prior therapy
Must have received: surgery — frontline
completion of optimal surgery
Must have received: Stupp based adjuvant chemo-radiotherapy — frontline
completion of optimal surgery, and Stupp based adjuvant chemo-radiotherapy (or equivalent)
Cannot have received: cytotoxic chemotherapy
Cytotoxic chemotherapy during the prior 2 weeks or 6 weeks for nitrosoureas
Cannot have received: nitrosourea
6 weeks for nitrosoureas
Cannot have received: bevacizumab (bevacizumab)
Bevacizumab during the prior 6 weeks
Cannot have received: immune checkpoint inhibitor
Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted
Cannot have received: EGFR-targeting therapy
Prior EGFR-targeting therapy is not permitted
Cannot have received: vaccine therapy
Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted
Cannot have received: other immune-modulatory investigational agent
Exception: must be discussed with sponsor team and CI
Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI
Lab requirements
Blood counts
Haemoglobin (Hb): ≥ 10.0 g/dL; Absolute neutrophil count: ≥ 1.5 x 10^9/L; Platelet count: ≥ 75 x 10^9/L; Coagulation: INR <1.5 and APTT <1.5x if not anticoagulated; INR stable > 7 days within intended therapeutic range if anticoagulated
Kidney function
Creatinine: <1.5 x ULN and creatinine clearance > 45 ml/min as measured or calculated based on Cockcroft-Gault formula
Liver function
Bilirubin: ≤ 1.5 x ULN; subjects with Gilbert's syndrome can enrol if conjugated bilirubin is within normal limits. ALT and AST: < 3 x ULN. Albumin: ≥ 28 g/L
Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP: ... (see details above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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