A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    330
  • sponsor
    VelosBio Inc.
Updated on 9 August 2022
renal function
cancer
myeloid leukemia
hematologic malignancy
cyclophosphamide
chronic lymphocytic leukemia
tyrosine
lymphoma
hydroxyurea
acute leukemia
cytarabine
HIV Infection
antiviral
leukemia
bone marrow procedure
lymphocytic leukemia
progressive disease
chemotherapy regimen
follicular lymphoma
cancer chemotherapy
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
immunoglobulin
marginal zone lymphoma
renal function tests
large b-cell lymphoma
lymphadenopathy
b-cell small lymphocytic lymphoma

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).

Details
Condition Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Diffuse Large B-cell Lymphoma, Richter Transformation Lymphoma, Burkitt Lymphoma, Lymphoplasmacytoid Lymphoma, T-cell Non-Hodgkin Lymphoma, Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Waldenstrom Macroglobulinemia
Treatment VLS-101, VLS-101 Schedule 1, VLS-101 Schedule 2, VLS-101 Schedule 3, Zilovertamab vedotin
Clinical Study IdentifierNCT03833180
SponsorVelosBio Inc.
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women of age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Histological diagnosis of CLL/SLL, MCL, FL, MZL, DLBCL, RTL, BL, LPL/WM, T-cell NHL, ALL, or AML as documented in medical records
Hematological cancer has been previously treated and has progressed during or relapsed after prior systemic therapy
Hematological cancer is unlikely to be responsive to established therapies known to provide clinical benefit or the study candidate has developed an intolerance to established therapies known to provide clinical benefit
Presence of measurable cancer including CLL/SLL, MCL, FL, MZL, DLBCL, RTL, BL, LPL/WM, T-cell NHL, ALL, and AML
Current medical need for therapy due to disease-related symptoms or complications, cytopenias, lymphadenopathy, organomegaly, extranodal organ involvement, or progressive disease
Availability of pretreatment tumor tissue
Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study therapy
All acute toxic effects of any prior antitumor therapy (not including hydroxyurea, cytarabine, and/or cyclophosphamide used in subjects with acute leukemia) resolved to ≤Grade 1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted] or selected laboratory parameters [Grade 1 or Grade 2 permitted with exceptions
Adequate bone marrow function
Adequate hepatic profile
Adequate renal function
Adequate coagulation profile
Negative antiviral serology
For female participants of childbearing potential, a negative serum pregnancy test
For both male and female participants, willingness to use protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy
Willingness and ability of the participant to comply with study activities
Evidence of a personally signed informed consent document
Previous treatment with an MMAE-containing drug is allowed

Exclusion Criteria

Presence of malignancy involving the central nervous system
Presence of another cancer with disease manifestations or therapy that could adversely affect participant safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results
Significant cardiovascular disease within 3 months prior to start of study therapy
Significant screening electrocardiogram (ECG) abnormalities
Uncontrolled ongoing systemic bacterial, fungal, or viral infection
Known diagnosis of liver cirrhosis
Pregnancy or breastfeeding
Candidacy for hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR)-T-cell therapy with access to HSCT or CAR-T cells and a willingness to undergo such therapy
Prior solid organ transplantation
In participants with prior HSCT, evidence of graft-versus-host disease (GVHD) with Grade ≥2 serum bilirubin, Grade ≥3 skin involvement, or Grade ≥3 diarrhea
Major surgery within 4 weeks before the start of study therapy
Prior therapy with a receptor tyrosine kinase-like orphan receptor 1 (ROR1)-directed therapy
Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4
Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks prior to Cycle 1 Day 1 (C1D1). If corticosteroid treatment is required for lymphoma symptom control prior to C1D1, up to 100 mg per day of prednisone equivalent can be given for up to 5 days. In that case, all tumor assessments must have been completed prior to the start of corticosteroid treatment
Use within 7 days prior to the start of study therapy of a drug known to prolong the QT interval
Concurrent participation in another therapeutic or imaging clinical trial
Presence of a medical condition that (in the judgement of the investigator) interferes with the ability of the participant to participate in the study
Has baseline peripheral neuropathy >Grade 1
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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