Clinical trial · Interventional
A Study of WVT078 in Patients With Multiple Myeloma (MM)
A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
NCT04123418CI-TRIAL-00099630terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The decision was made for business reasons and was not based on any safety or tolerability concerns
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WHG626 | Drug | — | UNRESOLVED |
| WVT078 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- WVT078 in Multiple Myeloma (MM) patients
- description
- Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
- interventionNames
- Biological: WVT078
- type
- EXPERIMENTAL
- label
- WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients
- description
- Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
- interventionNames
- Biological: WVT078
- Drug: WHG626
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRaab 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