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

Active:	No
Cancer Type:	Multiple Myeloma	NCT ID:	NCT04123418
Trial Phases:	Phase I	Protocol IDs:	CWVT078A12101 (primary) NCI-2021-09189
Eligibility:	18 - 99 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT04123418

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.

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