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

NCT ID: NCT05698888

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2023-06-19

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VP301 (Dose Escalation)

Eligible patients will receive VP301 administered as an IV infusion weekly for 6 weeks then every 2 weeks. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.

Group Type: EXPERIMENTAL

VP301

Intervention Type: DRUG

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

VP301 (Dose Expansion)

Eligible patients will receive VP301 administered as an IV infusion weekly for 6 weeks then every 2 weeks. Patients will receive the maximum tolerated dose or recommended phase 2 dose during the Dose Expansion period of the study.

Group Type: EXPERIMENTAL

VP301

Intervention Type: DRUG

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

Interventions

VP301

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis of a refractory solid tumor, refractory myeloma or lymphoma with measurable or evaluable disease
• Patients must have progressed following all therapies of known, potential clinical benefit, or for whom treatments of known clinical benefit are contraindicated.
• Adequate kidney, liver, and hematologic function
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria

• Active brain metastases and history of leptomeningeal metastases.
• Myeloma patients with plasmacytoma as only measurable disease
• Non-secretory myeloma
• Patients with advanced metastatic, symptomatic, visceral spread who are at risk of life-threatening complications
• Active or chronic, uncontrolled bacterial, viral, or fungal infection(s)
• Abnormal ECG
• Has clinically significant cardiovascular disease
• Additional active malignancy that may confound the assessment of the study endpoints
• Pregnancy or lactation
• Known seropositivity for HIV (human immunodeficiency virus) or active hepatitis B or hepatitis C

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virtuoso BINco, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NEXT Oncology

San Antonio, Texas, United States

Countries

United States

Other Identifiers

VP301-001

Identifier Type: -

Identifier Source: org_study_id