GCT1053-1: GEN1053 given alone or as combination and in patients with malignant solid tumors.
Research type
Research Study
Full title
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate the safety of GEN1053 as monotherapy and in combination with an immunomodulator in subjects with malignant solid tumors
IRAS ID
1005700
Contact name
Abdullah Ziad Al-Janabi
Contact email
Sponsor organisation
Genmab B.V.
Eudract number
2021-006692-42
Research summary
This is the first study investigating GEN1053 in humans. As such, the main purpose of the study is to make sure that GEN1053 is safe and tolerable. GEN1053 is a monoclonal antibody that binds a cell receptor molecule called CD27. CD27 affects the immune response, and its activation can lead to increased anti-tumour activity. The study is planned to investigate GEN1053 as both monotherapy and in combination with another immunomodulator drug. GEN1053 is developed to treat malignant solid tumours.
The study consists of two parts: a dose-escalation part and an expansion part. The purpose of the dose-escalation part is to find the highest tolerated and safest dose. GEN1053 will first be given at a low dose to a small group of study participants. If shown to be safe, the dose level will be increased and given to other groups of study participants until the maximum tolerable dose is reached. The dose escalation part just investigates GEN1053 as monotherapy.
In the expansion phase, the safest GEN1053 dose determined from the dose-escalation phase will be further investigated, in other study participants and as both monotherapy and in combination with another immunomodulator.
GEN1053 is given intravenously and as infusion every third week. All trial participants are given GEN1053.
The study is planned to be conducted globally.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0738
Date of REC Opinion
8 Dec 2022
REC opinion
Further Information Unfavourable Opinion