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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05698888
Other study ID # VP301-001
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date November 29, 2022
Est. completion date June 19, 2023

Study information

Verified date September 2023
Source Virtuoso BINco, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 19, 2023
Est. primary completion date June 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States NEXT Oncology San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Virtuoso BINco, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Tumor expression Evaluate ICAM-1 and CD38 expression with clinical outcomes through study completion, an average of 30 months
Other Immunoglobulins Evaluate quantitative immunoglobulins with clinical outcomes through study completion, an average of 30 months
Primary Occurrence of General Toxicity Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters through study completion, an average of 30 months
Primary Occurrence of Dose Limiting Toxicity Incidence of dose limiting toxicity during cycle 1 of dose escalation Over the first 21 days of VP301 dosing
Secondary Serum concentrations of VP301 Change from baseline in serum levels through study completion, an average of 30 months
Secondary Antidrug and neutralizing antibodies Change from baseline in serum levels through study completion, an average of 30 months
Secondary Objective response Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors through study completion, an average of 30 months
Secondary Best response Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors through study completion, an average of 30 months
Secondary Time to response and duration of response Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma through study completion, an average of 30 months
Secondary Progression-free survival Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma through study completion, an average of 30 months
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