This is a Phase 1/2 study designed to evaluate the safety and tolerability of BION-1301 in adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or more prior systemic therapies.
An open-label, multi-center, dose-selection Phase 1/2 study (also referred to as ADU-CL-16) evaluating BION-1301, a humanized monoclonal antibody directed against APRIL for the treatment of relapsed or refractory MM. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and initial clinical activity of BION-1301 administered as a single agent. The study will be conducted in 2 parts. Phase 1 is dose escalation and seeks to determine the recommended phase 2 dose (RP2D). Once an RP2D is identified, Phase 2 of the study will open and continue to evaluate the safety and preliminary efficacy of BION-1301 administered at selected dose level(s). The population for this study will consist of adults with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies. BION-1301 will be administered in 28-day cycles; the dosing interval will be once every two weeks (Q2W).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
a solution for intravenous (IV) administration, diluted and administered Q2W
James R. Berenson, MD, Inc
West Hollywood, California, United States
Winship Cancer Institute/Emory University
Atlanta, Georgia, United States
Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States
UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center
Safety (Phase 1)
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
Time frame: 28 days following first administration of BION-1301
Recommended Phase 2 Dose (Phase 1)
Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent
Time frame: Approximately 2 years
Biomarkers (Phase 1 and 2)
Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
Time frame: Baseline and approximately 2 years
Bioanalytical Measures (Phase 1 and Phase 2)
Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline
Time frame: Baseline and approximately 2 years
Safety Profile (Phase 2)
BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities
Time frame: 28 days
Response Rate (Phase 2)
Objective response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)
Time frame: Approximately 30 months
Progression-Free Survival (Phase 2)
Progression-free survival (PFS) defined as time from first dose of study drug to date of first tumor progression or death due to any cause
Time frame: Approximately 30 months
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Pittsburgh, Pennsylvania, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Overall Survival (Phase 2)
Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause
Time frame: Approximately 30 months