Multiple Myeloma Clinical Trial
A Study of WVT078 in Patients With Multiple Myeloma (MM)
Summary
The design of a phase I, open-label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent WVT078 alone and in combination with WHG626 in patients relapses and/or refractory Multiple Myeloma (MM)
Full Description
This first-in-human trial with WVT078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with MM who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. In addition, this study will assess preliminary anti-MM response of and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with WHG626. The results of this study will inform the future development of WVT078 alone and in combination with WHG626 as a treatment for relapsed and/or refractory MM.
Eligibility Criteria
Inclusion Criteria:
Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
Exclusion Criteria:
Use of systemic chronic steroid therapy (>or= 10mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment
Malignant disease other than being treated on this study
Active known or suspected autoimmune disease
Impaired cardiac function or clinically significant cardiac disease
Treatment with cytotoxic or small molecule antineoplastics or any experimental therapy within 14 days or 5 half-lives whichever is shorter
Active central nervous system involvement by malignancy or presence of symptomatic CNS metasteses
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There are 12 Locations for this study
Atlanta Georgia, 30322, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Prahran Victoria, 3181, Australia
Dresden , 01307, Germany
Heidelberg , 69120, Germany
Tel Aviv , 64239, Israel
Milano MI, 20162, Italy
Bunkyo ku Tokyo, 113-8, Japan
Oslo , NO 04, Norway
Santander Cantabria, 39008, Spain
Barcelona , 08041, Spain
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