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A Study of WVT078 in Patients With Multiple Myeloma (MM)

Status
Closed
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 - 99 Years, Male and Female
Study Type
Treatment
NCT ID
NCT04123418
Protocol IDs
CWVT078A12101 (primary)
NCI-2021-09189
Study Sponsor
Novartis Pharmaceuticals Corporation

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)

Objectives

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

  1. Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
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