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TerminatedNCT05698888Updated Sep 21, 2023

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

A Phase 1 interventional study of VP301 in Solid Tumors, Adult, Multiple Myeloma and Lymphoma, sponsored by Virtuoso BINco, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Virtuoso BINco, Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Sponsor Decision

From the registry’s dates

  • Primary completion was Jun 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Solid Tumors, Adult
  • Multiple Myeloma
  • Lymphoma
03

In context

Multiple Myeloma

3,713 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's enrollment of 2 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

This is the only study on the registry with Virtuoso BINco, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    VP301 (Dose Escalation)

    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

  • Experimental
    VP301 (Dose Expansion)

    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

  • DrugVP301

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. Serum concentrations of VP301

    Change from baseline in serum levels

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

  2. Antidrug and neutralizing antibodies

    Change from baseline in serum levels

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

  3. 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

  4. 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

  5. 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

  6. Progression-free survival

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

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

Other outcomes

  1. Tumor expression

    Evaluate ICAM-1 and CD38 expression with clinical outcomes

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

  2. Immunoglobulins

    Evaluate quantitative immunoglobulins with clinical outcomes

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

07

Study locations

1 site
  • NEXT Oncology
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2022 to primary completion in Jun 2023, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2022
First posted
Jan 26, 2023
StartActual
Nov 29, 2022
Primary completionActual
Jun 19, 2023
CompletionActual
Jun 19, 2023
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05698888
Lead sponsor
Virtuoso BINco, Inc.
Responsible party
Sponsor
First posted
Jan 26, 2023
Start date
Nov 29, 2022
Primary completion
Jun 19, 2023
Completion
Jun 19, 2023
Last update
Sep 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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