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5G-EMERALD: Amivantamab in Malignant Brain Tumours

NCT06632236 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-25

No results posted yet for this study

Summary

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

  • Malignant Primary Gliomas
  • Glioblastoma Multiform (Grade IV Astrocytoma)
  • Diffuse Hemispheric Glioma, H3 G34-Mutant
  • Glioblastoma Multiforme (GBM)

Interventions

DRUG

Amivantamab

Amivantamab will be supplied in single-use 350 mg injectable solution, provided as a 7 ml per glass vial (50mg/ml), intended for IV infusion.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • Cancer Research UK

    collaborator OTHER

  • Minderoo Foundation

    collaborator UNKNOWN

  • University of Cambridge

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Juanita Lopez, MD, PhD · National Health Service, UK

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2026-03-05
Completion
2027-03-05

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06632236 on ClinicalTrials.gov