Clinical trial NCT05698888: Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumors, Adult
Multiple Myeloma
Lymphoma
Lead sponsor: Virtuoso BINco, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Occurrence of General Toxicity
timeFrame: through study completion, an average of 30 months
measure: Occurrence of Dose Limiting Toxicity
timeFrame: Over the first 21 days of VP301 dosing
Secondary outcomes:
measure: Serum concentrations of VP301
timeFrame: through study completion, an average of 30 months
measure: Antidrug and neutralizing antibodies
timeFrame: through study completion, an average of 30 months
measure: Objective response
timeFrame: through study completion, an average of 30 months
measure: Best response
timeFrame: through study completion, an average of 30 months
measure: Time to response and duration of response
timeFrame: through study completion, an average of 30 months
measure: Progression-free survival
timeFrame: through study completion, an average of 30 months
Other outcomes:
measure: Tumor expression
timeFrame: through study completion, an average of 30 months
measure: Immunoglobulins
timeFrame: through study completion, an average of 30 months
Locations:
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
Study officials:
References: