A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS-101 in Subjects With Hematological Malignancies (waveLINE-001)
Sponsor: VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Maximum tolerated dose (MTD) of zilovertamab vedotin
Time frame: Cycle 1 (Up to 21 Days)
Recommended Dosing Regimen (RDR)
Time frame: Cycle 1 (Up to 21 Days)
Secondary Endpoints
Average number of zilovertamab vedotin infusions administered
Number of participants with a treatment-emergent adverse event (TEAE)
Number of participants with a DLT
Eligibility Criteria
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 under study 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 (i…
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