A study switching people with haemophilia A from emicizumab to Mim8 (Frontier 5)
Research type
Research Study
Full title
Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis
IRAS ID
1007294
Contact name
Clinical Transparency Dept 2834
Contact email
Sponsor organisation
Novo Nordisk A/S
Clinicaltrials.gov Identifier
Research summary
This study is researching an investigational drug called REGN7075 by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe and tolerable REGN7075 is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of REGN7075 to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective REGN7075 by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.
The study is also looking at:
• Side effects that may be experienced by people taking REGN7075 by itself and in combination with cemiplimab with or without chemotherapy
• How REGN7075 works in the body by itself and in combination with cemiplimab with or without chemotherapy
• How much REGN7075 is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
• To see if REGN7075 by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumorREC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0303
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion