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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Solid Tumors, Adult, Multiple Myeloma, Lymphoma

Intervention / Treatment
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* Drug: VP301


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VP301 (Dose Escalation)<br>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. | Drug: VP301<br>* VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.<br>|
| Experimental: VP301 (Dose Expansion)<br>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. | Drug: VP301<br>* VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of General Toxicity | Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters | through study completion, an average of 30 months | 
| Occurrence of Dose Limiting Toxicity | Incidence of dose limiting toxicity during cycle 1 of dose escalation | Over the first 21 days of VP301 dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of VP301 | Change from baseline in serum levels | through study completion, an average of 30 months | 
| Antidrug and neutralizing antibodies | Change from baseline in serum levels | 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 | 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 | 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 | through study completion, an average of 30 months | 
| Progression-free survival | Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma | through study completion, an average of 30 months |