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Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT05698888•Virtuoso BINco, Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

November 29, 2022

Primary Completion Date

June 19, 2023

Completion Date

June 19, 2023

Last Updated

September 21, 2023

Enrollment

ACTUAL participants

Conditions

Solid Tumors, AdultMultiple MyelomaLymphoma

Interventions

VP301

DRUG

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

View study

RECRUITINGPHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma