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

Primary Purpose

Solid Tumors, Adult, Multiple Myeloma, Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VP301
Sponsored by
Virtuoso BINco, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NEXT Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

VP301 (Dose Escalation)

VP301 (Dose Expansion)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Occurrence of General Toxicity
Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters
Occurrence of Dose Limiting Toxicity
Incidence of dose limiting toxicity during cycle 1 of dose escalation

Secondary Outcome Measures

Serum concentrations of VP301
Change from baseline in serum levels
Antidrug and neutralizing antibodies
Change from baseline in serum levels
Objective response
Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors
Best response
Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors
Time to response and duration of response
Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma
Progression-free survival
Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma

Full Information

First Posted
December 12, 2022
Last Updated
September 15, 2023
Sponsor
Virtuoso BINco, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05698888
Brief Title
Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virtuoso BINco, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Adult, Multiple Myeloma, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Following completion of the dose escalation phase of the study and determination of maximum tolerated dose or recommended phase 2 dose, patients will be enrolled into dose expansion.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VP301 (Dose Escalation)
Arm Type
Experimental
Arm Description
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.
Arm Title
VP301 (Dose Expansion)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VP301
Intervention Description
VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.
Primary Outcome Measure Information:
Title
Occurrence of General Toxicity
Description
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
Title
Occurrence of Dose Limiting Toxicity
Description
Incidence of dose limiting toxicity during cycle 1 of dose escalation
Time Frame
Over the first 21 days of VP301 dosing
Secondary Outcome Measure Information:
Title
Serum concentrations of VP301
Description
Change from baseline in serum levels
Time Frame
through study completion, an average of 30 months
Title
Antidrug and neutralizing antibodies
Description
Change from baseline in serum levels
Time Frame
through study completion, an average of 30 months
Title
Objective response
Description
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
Title
Best response
Description
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
Title
Time to response and duration of response
Description
Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma
Time Frame
through study completion, an average of 30 months
Title
Progression-free survival
Description
Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma
Time Frame
through study completion, an average of 30 months
Other Pre-specified Outcome Measures:
Title
Tumor expression
Description
Evaluate ICAM-1 and CD38 expression with clinical outcomes
Time Frame
through study completion, an average of 30 months
Title
Immunoglobulins
Description
Evaluate quantitative immunoglobulins with clinical outcomes
Time Frame
through study completion, an average of 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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