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

Novartis

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma (MM)

Treatments: Drug: WHG626; Biological: WVT078

Study type: Interventional

Funder types: Industry

Identifiers

NCT04123418

CWVT078A12101

Details and patient eligibility

About

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)

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

WVT078 in Multiple Myeloma (MM) patients

Experimental group

Description:

Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)

Treatment:

Biological: WVT078

WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients

Experimental group

Description:

Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)

Treatment:

Drug: WHG626

Biological: WVT078