VP301 for Cancer

EB
JA
Overseen ByJill Abbey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VP301, an experimental therapy, to determine its safety and tolerability for individuals with certain cancers, such as multiple myeloma, lymphoma, or solid tumors, that have recurred or resisted other treatments. Participants will receive VP301 through an IV infusion, with doses adjusted to identify the most effective and safe amount. Those who have exhausted all other treatments without success and have stable organ function might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that VP301 is likely to be safe for humans?

Research has shown that VP301, a special type of antibody, has promising safety results. One study demonstrated that VP301 effectively fought myeloma, a type of cancer, with minimal harm to normal cells, indicating it is generally well-tolerated. Additionally, a 4-week study in monkeys found no harmful effects, suggesting it is safe.

However, like similar treatments, VP301 can cause side effects, such as infections or blood issues. Regular check-ups are crucial to detect any signs of infection early.

Overall, research suggests that VP301 is quite safe, but participants should remain vigilant and report any unusual symptoms to their healthcare team during the trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about VP301 because it introduces a new approach for treating multiple myeloma, lymphoma, and solid tumors. Unlike many current treatments that focus on chemotherapy or targeted therapies, VP301 is administered as an intravenous infusion and explores a novel dosing strategy with escalating doses to determine the most effective and safe levels. This dose escalation and expansion approach could potentially enhance treatment effectiveness while minimizing side effects, offering a tailored therapy option that could improve patient outcomes.

What evidence suggests that VP301 might be an effective treatment for relapsed or refractory multiple myeloma, lymphoma, or solid tumors?

Research has shown that VP301 could be a promising treatment for multiple myeloma and similar cancers. VP301 targets specific proteins on cancer cells, aiding the immune system in identifying and attacking these cells. Early results suggest this method effectively attaches to cancer cells, potentially reducing tumor size. Although clinical data on VP301 remains limited, its mechanism has shown promise in lab studies. In this trial, participants will receive VP301 in either a dose escalation or dose expansion arm, as part of a new group of cancer therapies designed to strengthen the body's natural defenses against cancer.24678

Are You a Good Fit for This Trial?

Inclusion Criteria

Histologic diagnosis of a refractory solid tumor, refractory myeloma or lymphoma with measurable or evaluable disease
Adequate kidney, liver, and hematologic function
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
See 1 more

Exclusion Criteria

Abnormal ECG
Active brain metastases and history of leptomeningeal metastases.
Myeloma patients with plasmacytoma as only measurable disease
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of VP301 to identify the maximum tolerated dose or recommended Phase 2 dose

6 weeks
Weekly IV infusions

Dose Expansion

Participants receive VP301 at the maximum tolerated dose or recommended Phase 2 dose

6 weeks
Weekly IV infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 months

What Are the Treatments Tested in This Trial?

Interventions

  • VP301
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: VP301 (Dose Expansion)Experimental Treatment1 Intervention
Group II: VP301 (Dose Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virtuoso BINco, Inc.

Lead Sponsor

Trials
1
Recruited
2+

Citations

Bispecific Antibodies for Multiple MyelomaAn updated study reported the results of the dose expansion study for IV ABBV-383. ABBV-383 demonstrated deep and enduring responses at doses ...
Study of VP301 in Patients With Multiple Myeloma, ...Dose escalation will evaluate the increasing doses of VP301 to determine the maximum tolerated dose or recommended Phase 2 dose.
CD38 x ICAM-1 Bispecific Antibody Is a Novel Approach for ...We evaluated VP301 binding to T cells by flow cytometry. The results revealed that daratumumab showed dose-dependent binding on T cells and the anti-CD38 mAb ...
Novel immunotargets in multiple myeloma - PubMed CentralThis review provides an overview of emerging immunotargets, summarizing their biological functions, roles in disease pathogenesis and immune evasion, and ...
Immunotherapy of Multiple Myeloma: Current Status as ...Overall, biweekly dosing was found to reduce total grade 3 or 4 adverse events from 58.6% to 46.6%, indicating that biweekly dosing may offer the advantage of ...
Study of VP301 in Patients With Multiple Myeloma ...What safety data exists for the treatment known as VP301 or valproic acid? Valproic acid (VPA) has been associated with serious liver problems, including liver ...
Bispecific Antibody Toxicity - StatPearls - NCBI Bookshelf - NIHOther bsAb side effects include infections, ICANS, and TLS. Regular monitoring for signs of infection, such as fever or localized symptoms, ...
Clinical Progresses and Challenges of Bispecific ...A 4-week toxicity study in monkeys revealed no adverse effects, indicating a favorable safety profile [58]. A Phase 1/2 clinical trial ...
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