Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632236
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
5G-EMERALD Amivantamab in Malignant Brain Tumours
Sponsor:
None
Organization:
None
Study Overview
Official Title:
5G-EMERALD A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5G-EMERALD
Brief 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
Progression to Phase 2 is dependent on emergent data and funding
Detailed Description:
The clinical trial will start in Phase 1b proof of concept of hypothesis-driven biomarker-guided therapies
This is a study within Minderoo 5G A Next Generation AGile Genomically Guided Glioma Modular Platform for proof-of-concept molecular hypothesis testing in patients with high grade malignant brain tumours
5G-EMERALD is a Bayesian multi-centre multi-arm open-label adaptive seamless Phase 1 trial of amivantamab for patients with high grade malignant brain tumours
5G-EMERALD will recruit patients with glioblastoma GBM into one molecularly-defined biomarker arm of patients who have tumours that harbour
EGFR amplification high copy number
The above mentioned arm within Phase 1 will have robust GOADAPT decision points reviewed by the Safety Review Committee SRC to allow for both agility and clear direction for next steps A 2-stage Bayesian adaptive design will be performed to assess preliminary efficacy
In the Phase 1b of this study a biomarker defined arm will be opened initially in the relapsed GBM setting enrolling 12 patients onto each arm These patients will be treated with amivantamab Amivantamab will be administered intravenously IV weekly for the first 4 weeks then every 2 weeks thereafter until disease progression or unacceptable toxicity
This is a study within Minderoo 5G A Next Generation AGile Genomically Guided Glioma Modular Platform for proof-of-concept molecular hypothesis testing in patients with high grade malignant brain tumours
5G-EMERALD is a Bayesian multi-centre multi-arm open-label adaptive seamless Phase 1 trial of amivantamab for patients with high grade malignant brain tumours
5G-EMERALD will recruit patients with glioblastoma GBM into one molecularly-defined biomarker arm of patients who have tumours that harbour
EGFR amplification high copy number
The above mentioned arm within Phase 1 will have robust GOADAPT decision points reviewed by the Safety Review Committee SRC to allow for both agility and clear direction for next steps A 2-stage Bayesian adaptive design will be performed to assess preliminary efficacy
In the Phase 1b of this study a biomarker defined arm will be opened initially in the relapsed GBM setting enrolling 12 patients onto each arm These patients will be treated with amivantamab Amivantamab will be administered intravenously IV weekly for the first 4 weeks then every 2 weeks thereafter until disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None