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)
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
Interventions
| Drug | Synonyms | Arms |
|---|
| WVT078 | | WVT078 in Multiple Myeloma (MM) patients |
| WHG626 | | WVT078 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
| Name | Type | Description | Interventions |
|---|
| WVT078 in Multiple Myeloma (MM) patients | Experimental | Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM) | |
| WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients | Experimental | Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (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
| 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
July 20, 2021
