Clinical Trials /

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

NCT04123418

Description:

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)

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CWVT078A12101
  • NCT ID: NCT04123418

Conditions

  • Multiple Myeloma (MM)

Interventions

DrugSynonymsArms
WVT078WVT078 in Multiple Myeloma (MM) patients
WHG626WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
WVT078 in Multiple Myeloma (MM) patientsExperimentalDose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
  • WVT078
WVT078 in combination with WHG626 in Multiple Myeloma (MM) patientsExperimentalDose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
  • WVT078
  • WHG626

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose limiting toxicity (DLTs) in Cycle 1
Time Frame:28 days (first cycle)
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Best Overall Response (BOR)
Time Frame:Up to 36 months
Safety Issue:
Description:Response assessment per International Myeloma Working Group (IMWG) criteria
Measure:Duration of Response (DOR)
Time Frame:Up to 36 months
Safety Issue:
Description:Response assessment per International Myeloma Working Group (IMWG) criteria
Measure:Progresson Free Survival (PFS)
Time Frame:Up to 36 months
Safety Issue:
Description:Response assessment per International Myeloma Working Group (IMWG) criteria
Measure:AUC of WVT078 derived from serum concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Cmax of WVT078 derived from serum concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Cmin of WVT078 derived from serum concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Tmax of WVT078 derived from serum concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:T1/2 of WVT078 derived from serum concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:AUC of WHG626 derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Cmax of WHG626 derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Cmin of WHG626 derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Tmax of WHG626 derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:T1/2 of WHG626 derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:
Measure:T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations
Time Frame:Up to 28 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Multiple Myeloma, phase 1

Last Updated

February 24, 2021