Clinical trial NCT04123418: A Study of WVT078 in Patients With Multiple Myeloma (MM)
Official title: A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma (MM)
Keywords: Multiple Myeloma, phase 1
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Incidence of dose limiting toxicity (DLTs) in Cycle 1
timeFrame: 28 days (first cycle)
measure: Frequency of dose interruptions
timeFrame: Up to 28 months
measure: Frequency of discontinuations
timeFrame: up to 28 months
measure: Frequency of dose reductions
timeFrame: up to 28 months
measure: Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions
timeFrame: Up to 31 months
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Up to 36 months
measure: Duration of Response (DOR)
timeFrame: Up to 36 months
measure: Progresson Free Survival (PFS)
timeFrame: Up to 36 months
measure: AUC of WVT078 derived from serum concentrations
timeFrame: Up to 28 months
measure: Cmax of WVT078 derived from serum concentrations
timeFrame: Up to 28 months
measure: Cmin of WVT078 derived from serum concentrations
timeFrame: Up to 28 months
measure: Tmax of WVT078 derived from serum concentrations
timeFrame: Up to 28 months
measure: T1/2 of WVT078 derived from serum concentrations
timeFrame: Up to 28 months
measure: Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
timeFrame: Up to 28 months
measure: AUC of WHG626 derived from plasma concentrations
timeFrame: Up to 28 months
measure: Cmax of WHG626 derived from plasma concentrations
timeFrame: Up to 28 months
measure: Cmin of WHG626 derived from plasma concentrations
timeFrame: Up to 28 months
measure: Tmax of WHG626 derived from plasma concentrations
timeFrame: Up to 28 months
measure: T1/2 of WHG626 derived from plasma concentrations
timeFrame: Up to 28 months
measure: AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
timeFrame: Up to 28 months
measure: Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
timeFrame: Up to 28 months
measure: Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
timeFrame: Up to 28 months
measure: Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
timeFrame: Up to 28 months
measure: T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
timeFrame: Up to 28 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine-Winship Cancer Institute
state: Georgia
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Barcelona
country: Spain
facility: Novartis Investigative Site
Study officials:
References: