NCT04702425

VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)

A Phase Ib, Multicenter Study of VOB560 in Combination With MIK665 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to identify doses and schedules of VOB560 and MIK665 that can be safely given and to learn if the combination can have possible benefits for patients with Non-Hodgkin lymphoma (NHL), Multiple Myeloma (MM) or Acute Myeloid Leukemia (AML). VOB560 and MIK665 are selective and potent blockers respectively of the B-cell lymphoma 2 (BCL2) protein and of the myeloid cell leukaemia 1 (MCL1) protein, proteins that may protect tumor cells from undergoing cell death. VOB560 and MIK665 are designed to block the functions of the BCL2 and MCL1 proteins, so that the tumor cells that rely on these proteins undergo cell death. Preclinical data suggest that concomitant treatment with VOB560 in combination with MIK665 induces robust anti-tumor activity.

Detailed description

This was an open-label, non-randomized multi-center phase Ib dose-escalation study with dose expansion arms in four different patient populations. Patients received VOB560 in combination with MIK665 in a once a week (QW) schedule over 21 days cycle. Less frequent dosing schedules could be explored based on emerging data. Patients were to be treated until disease progression or unacceptable toxicities occurred. The study included a dose escalation part (Part 1) and a dose expansion part (Part 2). The following escalation arms were planned: * Arm A: relapsed/refractory (R/R) NHL and R/R MM * Arm B: R/R AML There were 4 expansion arms planned. However, the expansion part of the study was not initiated.

Conditions

• Non-Hodgkin Lymphoma (NHL)
• Acute Myeloid Leukemia (AML)
• Multiple Myeloma (MM)

Interventions

Type	Name	Description
DRUG	VOB560	Powder for concentrate for solution for infusion
DRUG	MIK665	Concentrate for solution for infusion

Timeline

• Start date: 2021-06-23
• Primary completion: 2024-07-23
• Completion: 2024-07-23
• First posted: 2021-01-08
• Last updated: 2025-10-10

Locations

9 sites across 9 countries: United States, Belgium, Finland, Hong Kong, Israel, Italy, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study