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

NCT05698888 | Terminated Phase 1 FDA Drug

• 1 other identifier: VP301-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors, Adult; Multiple Myeloma; Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Serum concentrations of VP301

  through study completion, an average of 30 months

• Antidrug and neutralizing antibodies

  through study completion, an average of 30 months

• Objective response

  through study completion, an average of 30 months

• Best response

  through study completion, an average of 30 months

• Time to response and duration of response

  through study completion, an average of 30 months

Other Outcomes (2)

• Tumor expression

  through study completion, an average of 30 months

• Immunoglobulins

  through study completion, an average of 30 months

Study Arms (2)

VP301 (Dose Escalation)

EXPERIMENTAL

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.

Drug: VP301

VP301 (Dose Expansion)

EXPERIMENTAL

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.

Drug: VP301

Interventions

VP301 DRUG

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

VP301 (Dose Escalation); VP301 (Dose Expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virtuoso BINco, Inc.: lead

Study Sites (1)

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 26, 2023
• Study Start: November 29, 2022
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)