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

Virtuoso BINco

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma; Lymphoma; Solid Tumors, Adult

Treatments: Drug: VP301

Study type: Interventional

Funder types: Industry

Identifiers

NCT05698888

VP301-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

VP301 (Dose Escalation)

Experimental group

Description:

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.

Treatment:

Drug: VP301

VP301 (Dose Expansion)

Experimental group

Description:

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.

Treatment:

Drug: VP301