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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05698888
• Other study ID #: VP301-001
• Status: Terminated
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Solid Tumors, Adult

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