NCT05698888

Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VP301 in Patients With Relapsed or Refractory Multiple Myeloma, Lymphoma, or Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Virtuoso BINco, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.

Detailed description

This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors. This study will be conducted in two parts: Dose Escalation - This part will evaluate increasing doses of VP301 to identify the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). The first patient enrolled on the study will receive the lowest dose of VP301. Once this dose is shown to be safe, an additional patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD or RP2D is reached. Dose Expansion - Patients with relapsed myeloma and lymphoma will be enrolled and treated with VP301 at the MTD or RP2D.

Conditions

• Solid Tumors, Adult
• Multiple Myeloma
• Lymphoma

Interventions

Type	Name	Description
DRUG	VP301	VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-06-19
• Completion: 2023-06-19
• First posted: 2023-01-26
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study