Multiple Myeloma Clinical Trial
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
Verified date | September 2023 |
Source | Virtuoso BINco, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.
Status | Terminated |
Enrollment | 2 |
Est. completion date | June 19, 2023 |
Est. primary completion date | June 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | NEXT Oncology | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Virtuoso BINco, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tumor expression | Evaluate ICAM-1 and CD38 expression with clinical outcomes | through study completion, an average of 30 months | |
Other | Immunoglobulins | Evaluate quantitative immunoglobulins with clinical outcomes | through study completion, an average of 30 months | |
Primary | 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 | |
Primary | 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 | Serum concentrations of VP301 | Change from baseline in serum levels | through study completion, an average of 30 months | |
Secondary | Antidrug and neutralizing antibodies | Change from baseline in serum levels | through study completion, an average of 30 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Progression-free survival | Assessed by IMWG for multiple myeloma or the Lugano criteria for lymphoma | through study completion, an average of 30 months |
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