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

Multiple Myeloma (MM) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04123418
• Other study ID #: CWVT078A12101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 5, 2019
• Est. completion date: December 2, 2024

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 2, 2024
• Est. primary completion date: November 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma (MM)
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Prahran	Victoria
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Heidelberg
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Milano	MI
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Norway	Novartis Investigative Site	Oslo
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
United States	Emory University School of Medicine/Winship Cancer Institute .	Atlanta	Georgia
United States	University of Wisconsin	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Israel,  Italy,  Japan,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicity (DLTs) in Cycle 1	To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM	28 days (first cycle)
Primary	Frequency of dose interruptions	To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM	Up to 28 months
Primary	Frequency of discontinuations	To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM	up to 28 months
Primary	Frequency of dose reductions	To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM	up to 28 months
Primary	Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions	To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM	Up to 31 months
Secondary	Best Overall Response (BOR)	Response assessment per International Myeloma Working Group (IMWG) criteria	Up to 36 months
Secondary	Duration of Response (DOR)	Response assessment per International Myeloma Working Group (IMWG) criteria	Up to 36 months
Secondary	Progresson Free Survival (PFS)	Response assessment per International Myeloma Working Group (IMWG) criteria	Up to 36 months
Secondary	AUC of WVT078 derived from serum concentrations		Up to 28 months
Secondary	Cmax of WVT078 derived from serum concentrations		Up to 28 months
Secondary	Cmin of WVT078 derived from serum concentrations		Up to 28 months
Secondary	Tmax of WVT078 derived from serum concentrations		Up to 28 months
Secondary	T1/2 of WVT078 derived from serum concentrations		Up to 28 months
Secondary	Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum		Up to 28 months
Secondary	AUC of WHG626 derived from plasma concentrations		Up to 28 months
Secondary	Cmax of WHG626 derived from plasma concentrations		Up to 28 months
Secondary	Cmin of WHG626 derived from plasma concentrations		Up to 28 months
Secondary	Tmax of WHG626 derived from plasma concentrations		Up to 28 months
Secondary	T1/2 of WHG626 derived from plasma concentrations		Up to 28 months
Secondary	AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations		Up to 28 months
Secondary	Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations		Up to 28 months
Secondary	Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations		Up to 28 months
Secondary	Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations		Up to 28 months
Secondary	T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations		Up to 28 months