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Sponsor Decision
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VP301 (Dose Escalation) | Experimental | 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. |
|
| VP301 (Dose Expansion) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VP301 | Drug | VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor expression | Evaluate ICAM-1 and CD38 expression with clinical outcomes | through study completion, an average of 30 months |
| Immunoglobulins | Evaluate quantitative immunoglobulins with clinical outcomes |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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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.
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| 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 |
| through study completion, an average of 30 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |