GCT1046-05
Research type
Research Study
Full title
A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer
IRAS ID
1007718
Contact name
Genmab Trial Information
Contact email
Sponsor organisation
Genmab A/S
Research summary
This is a phase 2, exploratory, open-label, unblinded, multicenter, single arm, interventional trial in patients with advanced (unresectable and/or metastatic) endometrial cancer to evaluate the safety and clinical activity of GEN1046 in combination with immunotherapy.
The trial drug is an experimental drug. This means that it has not yet been approved to treat endometrial cancer. The trial drug used in this trial is called GEN1046 (DuoBody®-PD-L1x4-1BB). In this trial GEN1046 is being tested in combination with Keytruda (pembrolizumab) to treat endometrial cancer.
Keytruda (pembrolizumab) is an approved immunotherapy treatment that works by helping patient`s immune system to fight the cancer. Keytruda (pembrolizumab) has also been approved as a treatment for patients with certain types of endometrial cancer.
The trial consists of two parallel treatment groups: Treatment Group A and Treatment Group B. Patient can only be treated in one treatment group, either in Group A or in Group B. Trial doctor will assign patient to the treatment group which is right for her, based on eligibility criteria.
Approximately 80 patients will be treated in Treatment Groups A and B (approximately 40 in each treatment group).
The trial consists of 3 phases:
1. Screening phase: up to a maximum of 35 days prior to the first dose of trial drugs.
2. An estimated 24-month treatment period (the duration of treatment may vary for each patient) (these are an estimated 35 clinic visits).
3. Follow-up phase: safety follow-up 30 days after the last dose of trial drugs and additional follow-up contacts every 12 weeks after the last dose of trial drugs.After the end of the trial, Genmab will make their best efforts to provide continued treatment with
GEN1046 in accordance with local laws and requirements if you benefit from the treatment.REC name
Wales REC 2
REC reference
23/WA/0154
Date of REC Opinion
19 Sep 2023
REC opinion
Further Information Favourable Opinion