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

VP301-001

This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.

2022-11-29

2023-06-19

2023-06-19

Terminated

Early phase I

2

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

2023-09-21