GCT1047-01: GEN1047 for Solid Tumors – FIH trial
Research type
Research Study
Full title
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors.
IRAS ID
1007620
Contact name
Nikit Bhatt
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2021-001790-23
Clinicaltrials.gov Identifier
Research summary
This is an First-In-Human (FIH), open-label, multinational, multicenter trial to evaluate the safety, PK, pharmacodynamics, and preliminary efficacy of GEN1047. GEN1047 will be administered as an IV infusion to a mixed population of subjects with solid tumours.
The trial consists of 2 consecutive parts: a Dose Escalation and an Expansion. The Dose Escalation part will consist of step-up dosing cohorts (SDCs) explored in an accelerated titration part (i.e., single-subject cohorts), followed by a standard titration part (i.e., standard 3-subject cohorts). The Expansion part will consist of parallel cohorts, by type of cancer; triple negative breast cancer (TNBC), endometrial cancer, or platinum-resistant ovarian cancer (PROC).
The UK will only participate in the Expansion part and only female participants will be eligible due to the types of cancer being studied.
In the Expansion part, there will be four groups and this part of the trial will test up to two doses of GEN1047 in two stages (Stage 1 and Stage 2). In Stage 1, there are two groups:
1. Group 1: Patients with PROC. These patients may be randomised to 1 of the 2 doses selected from the Escalation part. Randomisation means that participants will be randomly assigned to 1 out of 2 doses (like the flip of a coin). Neither the participant nor trial doctor has any influence on which dose will be receive.
2. Group 2: Patients with TNBC and endometrial cancer. These patients will all receive the same dose. The information obtained from the PROC group in Stage 1 will be used to decide on the dose to be used in Stage 2.
GEN1047 is a combination of two antibodies. It was designed to stimulate part of the immune system called T cells, while at the same time binding to cancer cells expressing a surface marker called B7H4. GEN1047 belongs to a group of drugs known as immunotherapy. It works by using the immune system to fight cancer. Some tumours are able to hide from the immune system by inactivating the T cells.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0357
Date of REC Opinion
10 Jul 2023
REC opinion
Further Information Favourable Opinion