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

Phase 1TerminatedNCT05698888

Virtuoso BINco, Inc.2 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors, Adult Multiple Myeloma Lymphoma

Interventions

VP301DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NEXT Oncology

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Occurrence of General Toxicity

Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters

Time frame: through study completion, an average of 30 months

Occurrence of Dose Limiting Toxicity

Incidence of dose limiting toxicity during cycle 1 of dose escalation

Time frame: Over the first 21 days of VP301 dosing

Secondary Outcomes

Serum concentrations of VP301

Change from baseline in serum levels

Time frame: through study completion, an average of 30 months

Antidrug and neutralizing antibodies

Change from baseline in serum levels

Time frame: through study completion, an average of 30 months

Objective response

Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors

Time frame: through study completion, an average of 30 months

Best response

Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors

Time frame: through study completion, an average of 30 months

Time to response and duration of response

Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma

Time frame: through study completion, an average of 30 months

Progression-free survival

Data from ClinicalTrials.gov

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