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

Overseen By Jill Abbey

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virtuoso BINco, Inc.

Disqualifiers: Brain metastases, Plasmacytoma, Non-secretory myeloma, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, VP301, in patients whose cancers have returned or did not respond to previous treatments. It aims to find the safest and most effective dose by adjusting the amount given over time.

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.

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 failure, especially when used with other medications. It can also cause adverse effects in children related to how the body processes the drug, and testing for certain genetic factors may help reduce these risks. ^{1 2 3 4 5}

Eligibility Criteria

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

Exclusion Criteria

Abnormal ECG

Active brain metastases and history of leptomeningeal metastases.

Myeloma patients with plasmacytoma as only measurable disease

Timeline

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

Treatment Details

Interventions

• VP301

Participant Groups

Group I: VP301 (Dose Expansion) Experimental Treatment 1 Intervention

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.

Group II: VP301 (Dose Escalation) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Virtuoso BINco, Inc.

Lead Sponsor

Trials

1

Recruited

2+

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic interaction on valproic acid and recurrence of epileptic seizures during chemotherapy in an epileptic patient. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical significance of CYP2C9-status guided valproic acid therapy in children. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Hydroxamic acid and fluorinated derivatives of valproic acid: anticonvulsant activity, neurotoxicity and teratogenicity. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Evolving anticancer drug valproic acid: insights into the mechanism and clinical studies. [2013]

5. Germany pubmed.ncbi.nlm.nih.gov

Non-fatal and fatal liver failure associated with valproic acid. [2016]