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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04123418

Studienbeginn:
Dezember 2019

Letztes Update:
20.11.2020

Wirkstoff:
WVT078, WHG626

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Kontakt

Studienlocations (3 von 9)

Novartis Investigative Site
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
3181 Prahran
AustraliaRekrutierend» Google-Maps
Novartis Investigative Site
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Novartis Investigative Site
113-8677 Bunkyo ku
JapanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of dose limiting toxicity (DLTs) in Cycle 1 (Time Frame - 28 days (first cycle)):
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

2. Frequency of dose interruptions (Time Frame - Up to 28 months):
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

3. Frequency of discontinuations (Time Frame - up to 28 months):
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

4. Frequency of dose reductions (Time Frame - up to 28 months):
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

5. Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions (Time Frame - Up to 31 months):
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:

1. Best Overall Response (BOR) (Time Frame - Up to 36 months):
Response assessment per International Myeloma Working Group (IMWG) criteria

2. Duration of Response (DOR) (Time Frame - Up to 36 months):
Response assessment per International Myeloma Working Group (IMWG) criteria

3. Progresson Free Survival (PFS) (Time Frame - Up to 36 months):
Response assessment per International Myeloma Working Group (IMWG) criteria

4. AUC of WVT078 derived from serum concentrations (Time Frame - Up to 28 months)

5. Cmax of WVT078 derived from serum concentrations (Time Frame - Up to 28 months)

6. Cmin of WVT078 derived from serum concentrations (Time Frame - Up to 28 months)

7. Tmax of WVT078 derived from serum concentrations (Time Frame - Up to 28 months)

8. T1/2 of WVT078 derived from serum concentrations (Time Frame - Up to 28 months)

9. Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum (Time Frame - Up to 28 months)

10. AUC of WHG626 derived from plasma concentrations (Time Frame - Up to 28 months)

11. Cmax of WHG626 derived from plasma concentrations (Time Frame - Up to 28 months)

12. Cmin of WHG626 derived from plasma concentrations (Time Frame - Up to 28 months)

13. Tmax of WHG626 derived from plasma concentrations (Time Frame - Up to 28 months)

14. T1/2 of WHG626 derived from plasma concentrations (Time Frame - Up to 28 months)

15. AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations (Time Frame - Up to 28 months)

16. Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations (Time Frame - Up to 28 months)

17. Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations (Time Frame - Up to 28 months)

18. Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations (Time Frame - Up to 28 months)

19. T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations (Time Frame - Up to 28 months)

Studien-Arme

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

Geprüfte Regime

  • WVT078:
    WVT078 will be administered IV (intravenously) in a dose escalation schedule
  • WHG626:
    WHG626 will be administered orally in a dose escalation schedule

Quelle: ClinicalTrials.gov


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