5G-EMERALD: Amivantamab in Malignant Brain Tumours

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT06632236
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 9, 2024
Status verified
Apr 2025
Primary completion
Mar 5, 2026
Completion
Mar 5, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Experimental: Phase 1b
    The Phase 1b will evaluate the safety and tolerability of amivantamab and determine its preliminary antitumour activity when administered at the recommended Phase 2 dose (RP2D) in patients with molecularly defined malignant brain tumours.

Primary Outcome Measure

Phase 1b - To evaluate the safety and tolerability of investigational agent in patients with malignant brain tumours [ Time Frame: 18 months ]

Central Contacts

Related Studies