Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VP301 (Dose Escalation) 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
VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.
|
| Experimental: VP301 (Dose Expansion) 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
VP301 is an afucosylated humanized Fc-modified immunoglobulin G1 (IgG1) bispecific antibody targeting CD38 and ICAM-1.
|
Outcome Measures
Primary Outcome Measures
- 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
- Occurrence of Dose Limiting Toxicity [Over the first 21 days of VP301 dosing]
Incidence of dose limiting toxicity during cycle 1 of dose escalation
Secondary Outcome Measures
- Serum concentrations of VP301 [through study completion, an average of 30 months]
Change from baseline in serum levels
- 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
- 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
- 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
Other Outcome Measures
- 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
Eligibility Criteria
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
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Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclusion Criteria:
-
Active brain metastases and history of leptomeningeal metastases.
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Myeloma patients with plasmacytoma as only measurable disease
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Non-secretory myeloma
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Patients with advanced metastatic, symptomatic, visceral spread who are at risk of life-threatening complications
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Active or chronic, uncontrolled bacterial, viral, or fungal infection(s)
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Abnormal ECG
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Has clinically significant cardiovascular disease
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Additional active malignancy that may confound the assessment of the study endpoints
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Pregnancy or lactation
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Known seropositivity for HIV (human immunodeficiency virus) or active hepatitis B or hepatitis C
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NEXT Oncology | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Virtuoso BINco, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VP301-001