Lymphoma, Multiple Myeloma, Solid Tumors, Adult
Conditions
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.
Interventions
DRUGVP301
VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.
Sponsors
Virtuoso BINco, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Dose Limiting Toxicity | Over the first 21 days of VP301 dosing | Incidence of dose limiting toxicity during cycle 1 of dose escalation |
| Occurrence of General Toxicity | through study completion, an average of 30 months | Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antidrug and neutralizing antibodies | through study completion, an average of 30 months | Change from baseline in serum levels |
| Objective response | through study completion, an average of 30 months | Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors |
| Time to response and duration of response | through study completion, an average of 30 months | Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma |
| Progression-free survival | through study completion, an average of 30 months | Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma |
| Best response | through study completion, an average of 30 months | Assessed by IMWG for multiple myeloma, the Lugano criteria for lymphoma or RECIST 1.1 for solid tumors |
| Serum concentrations of VP301 | through study completion, an average of 30 months | Change from baseline in serum levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor expression | through study completion, an average of 30 months | Evaluate ICAM-1 and CD38 expression with clinical outcomes |
| Immunoglobulins | through study completion, an average of 30 months | Evaluate quantitative immunoglobulins with clinical outcomes |
Countries
United States
Outcome results
None listed