NCT04123418

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

A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Multiple Myeloma (MM)

Interventions

Type	Name	Description
BIOLOGICAL	WVT078	WVT078 will be administered IV (intravenously) in a dose escalation schedule
DRUG	WHG626	WHG626 will be administered orally in a dose escalation schedule

Timeline

• Start date: 2019-12-05
• Primary completion: 2024-12-02
• Completion: 2024-12-02
• First posted: 2019-10-10
• Last updated: 2025-12-24

Locations

12 sites across 8 countries: United States, Australia, Germany, Israel, Italy, Japan, Norway, Spain

Regulatory

• FDA-regulated drug study