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

NCT04123418 | Terminated Phase 1 FDA Drug

• 1 other identifier: CWVT078A12101
• Study Type: interventional
• Target: 56
• Locations: 8 countries
• Sites: 12

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)

Conditions

Multiple Myeloma (MM)

Keywords

Multiple Myeloma, phase 1

Outcome Measures

Primary Outcomes (5)

• Incidence of dose limiting toxicity (DLTs) in Cycle 1

  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

  28 days (first cycle)

• Frequency of dose interruptions

  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

  Up to 28 months

• Frequency of discontinuations

  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

  up to 28 months

• Frequency of dose reductions

  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

  up to 28 months

• Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions

  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

  Up to 31 months

Secondary Outcomes (19)

• Best Overall Response (BOR)

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Progresson Free Survival (PFS)

  Up to 36 months

• AUC of WVT078 derived from serum concentrations

  Up to 28 months

• Cmax of WVT078 derived from serum concentrations

  Up to 28 months

Study Arms (2)

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)

Biological: WVT078

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)

Biological: WVT078; Drug: WHG626

Interventions

WVT078 BIOLOGICAL

WVT078 will be administered IV (intravenously) in a dose escalation schedule

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

WHG626 DRUG

WHG626 will be administered orally in a dose escalation schedule

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University Of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8677, Japan

Location

Novartis Investigative Site

Oslo, NO-0407, Norway

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Related Publications (1)

• Raab MS, Cohen YC, Schjesvold F, Aardalen K, Oka A, Spencer A, Wermke M, Souza AD, Kaufman JL, Cafro AM, Ocio EM, Doki N, Henson K, Trabucco G, Carrion A, Bender FC, Juif PE, Fessehatsion A, Fan L, Stonehouse JP, Blankenship JW, Granda B, De Vita S, Lu H. Preclinical discovery and initial clinical data of WVT078, a BCMA x CD3 bispecific antibody. Leukemia. 2023 Jun;37(6):1349-1360. doi: 10.1038/s41375-023-01883-3. Epub 2023 Apr 6.

  PMID: 37024520 DERIVED

Related Links

• CWVT078A12101 Clinical Trial Results Form
• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 10, 2019
• Study Start: December 5, 2019
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (3); ES (2); IL (1); NO (1); JP (1); IT (1); DE (2)