Solid Tumors, AdultPhase 1NCT05698888
Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors
A Phase 1 study testing VP301 in people with Solid Tumors, Adult and Multiple Myeloma, run by Virtuoso BINco, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Adult, Multiple Myeloma, Lymphoma
- What is being tested?
- VP301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 19 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Solid Tumors, Adult, Multiple Myeloma, Lymphoma
- Being tested
- VP301
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP301Drug
VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: VP301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of General Toxicity
Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters
Measured: through study completion, an average of 30 months
Occurrence of Dose Limiting Toxicity
Incidence of dose limiting toxicity during cycle 1 of dose escalation
Measured: Over the first 21 days of VP301 dosing
Secondary outcomes (6)
Serum concentrations of VP301
Change from baseline in serum levels
Measured: through study completion, an average of 30 months
Antidrug and neutralizing antibodies
Change from baseline in serum levels
Measured: through study completion, an average of 30 months
Objective response
Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors
Measured: through study completion, an average of 30 months
Best response
Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors
Measured: through study completion, an average of 30 months
Time to response and duration of response
Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma
Measured: through study completion, an average of 30 months
Progression-free survival
Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma
Measured: through study completion, an average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start29 Nov 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virtuoso BINco, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698888
- Sponsor's protocol ID
- VP301-001
- Status last verified
- Sep 2023
- First submitted
- 12 Dec 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05698888
- Acronym / sponsor ID
- VP301-001
- Conditions
- Solid Tumors, Adult, Multiple Myeloma, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virtuoso BINco, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VP301 (Dose Escalation) | Experimental | Drug: VP301Eligible 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. |
| VP301 (Dose Expansion) | Experimental | Drug: VP301Eligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VP301VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1. | Drug | VP301 (Dose Escalation), VP301 (Dose Expansion) |
Primary outcome
Occurrence of General Toxicity
Time frame: through study completion, an average of 30 months
Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters
Occurrence of Dose Limiting Toxicity
Time frame: Over the first 21 days of VP301 dosing
Incidence of dose limiting toxicity during cycle 1 of dose escalation
6 secondary outcomes
Serum concentrations of VP301
Time frame: through study completion, an average of 30 months
Antidrug and neutralizing antibodies
Time frame: through study completion, an average of 30 months
Objective response
Time frame: through study completion, an average of 30 months
Best response
Time frame: through study completion, an average of 30 months
Time to response and duration of response
Time frame: through study completion, an average of 30 months
Progression-free survival
Time frame: through study completion, an average of 30 months
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VP301 in people with Solid Tumors, Adult and Multiple Myeloma, run by Virtuoso BINco, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of General Toxicity (time frame: through study completion, an average of 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.