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Brief Title: Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
Official Title: A Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)
Study ID: NCT04903197
Brief Summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.
Detailed Description: The primary objective of the study is to evaluate the safety and tolerability in patients with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of VAY736 single agent and in combination with other anti-cancer therapies. This is a phase I/Ib, multi-center, open-label study with multiple treatment arms in an adaptive study design. The study is comprised of a dose escalation part and dose expansion part. In dose escalation, the investigational drug VAY736 will be explored alone or in combination with partner therapies. Increasing doses of VAY736 alone or in combination will be given to small groups of patients to identify the MTD/RD in patients with NHL. In dose expansion, some or all the treatments from dose escalation will be tested at the recommended doses in patients with NHL. Combination partners may be added in the future by protocol amendment. The study is expected to be approximately 4 years in duration (from enrollment of first patient to discontinuation of last patient).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City Of Hope National Med Ctr, Duarte, California, United States
The Ohio State University James Cancer Hospital &, Columbus, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Tianjin, , China
Novartis Investigative Site, Gottingen, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Brescia, BS, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Rozzano, MI, Italy
Novartis Investigative Site, Koto ku, Tokyo, Japan
Novartis Investigative Site, Yamagata, , Japan
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Name: Novartis Institutes of Biomedical Research
Affiliation: Novartis Institutes of Biomedical Research
Role: STUDY_DIRECTOR