R7945-ONC-22110
Research type
Research Study
Full title
A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an anti-CD38 x anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination with Linvoseltamab, an anti-BCMA x anti-CD3 Bispecific Monoclonal Antibody, in Participants with Relapsed/Refractory Multiple Myeloma
IRAS ID
1010594
Contact name
Tri Vo
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2024-513126-39
Research summary
This is a phase 1 (first in human) study to assess a new treatment for advanced multiple myeloma (MM). Multiple Myeloma is a type of blood cancer that affects plasma cells, which makes antibiotics to fight infections. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. This is an open-label study. This means that both the study doctor and participant will know which study drug(s) (REGN7945 and linvoseltamab or linvoseltamab alone) they receive. There are 2 parts in the study. The purpose of Part 1 will be to study the side effects and determine the recommended doses of the study drug(s) to be given in Phase 2. The purpose of Part 2 will be to continues to assess the side effects of the study drug(s) and to see how effective the study drug(s) is/are at treating multiple myeloma. The study will include about 186 people worldwide.
The length of participation in this study will vary depending upon participants response to treatment with the study drug(s) (either REGN7945 and linvoseltamab or linvoseltamab alone) and what side effects, if any, participants have from the study drug(s). Participants will receive treatment with study drug(s) for as long as the study drug(s) are helping to improve their multiple myeloma or until they experience worsening side effects or their myeloma gets worse.
Study procedures will include: Physical examinations, bone marrow biopsy, CT-scans, MRIs, ECGs, Echo, blood and urine tests and completion of questionnaires.REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0744
Date of REC Opinion
12 Dec 2024
REC opinion
Further Information Favourable Opinion