- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03340883
Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)
A Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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California
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West Hollywood, California, United States, 90069
- James R. Berenson, MD, Inc
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute/Emory University
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Wexner Medical Center James Cancer Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center
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Virginia
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Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists
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Washington
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Seattle, Washington, United States, 98104
- Swedish Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital & the Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
Individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol:
- Male or female, aged ≥ 18 years
- Confirmed diagnosis of MM per IMWG criteria
Measurable disease as defined by one or more of the following:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Serum Free Light Chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal
- In cases where SPEP is unreliable, serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL) is acceptable
- Relapsed or refractory (Rajkumar, 2011) to 3 or more different prior lines of therapy for MM, including immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), chemotherapies, or monoclonal antibodies, and not a candidate for, or intolerant to established therapy known to provide clinical benefit.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
- Adequate organ and marrow function at Screening, as defined by the study protocol.
Key Exclusion Criteria:
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenstrom's macroglobulinemia, or IgM myeloma
- Active plasma cell leukemia (˃ 2.0 × 109/L circulating plasma cells by standard differential)
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Prior treatment directed to B-cell Activating Factor (BAFF; BLyS), B-cell Maturation Antigen (BCMA;TNFSF17) or Transmembrane Activator and CAML interactor (TACI; TNFSF13B), including antibodies or BCMA- or TACI-directed Chimeric Antigen Receptor (CAR)-T cell therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: BION-1301
BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
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a solution for intravenous (IV) administration, diluted and administered Q2W
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (Phase 1)
Time Frame: 28 days following first administration of BION-1301
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Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
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28 days following first administration of BION-1301
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Recommended Phase 2 Dose (Phase 1)
Time Frame: Approximately 2 years
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Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent
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Approximately 2 years
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Biomarkers (Phase 1 and 2)
Time Frame: Baseline and approximately 2 years
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Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
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Baseline and approximately 2 years
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Bioanalytical Measures (Phase 1 and Phase 2)
Time Frame: Baseline and approximately 2 years
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Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline
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Baseline and approximately 2 years
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Safety Profile (Phase 2)
Time Frame: 28 days
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BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities
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28 days
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Response Rate (Phase 2)
Time Frame: Approximately 30 months
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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)
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Approximately 30 months
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Progression-Free Survival (Phase 2)
Time Frame: Approximately 30 months
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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
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Approximately 30 months
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Overall Survival (Phase 2)
Time Frame: Approximately 30 months
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Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause
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Approximately 30 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- ADU-CL-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on BION-1301
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Chinook Therapeutics, Inc.CompletedHealthy VolunteerUnited States
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Chinook Therapeutics, Inc.RecruitingImmunoglobulin A Nephropathy | IgA NephropathyUnited States, Canada, Australia, Argentina, Korea, Republic of
-
Chinook Therapeutics, Inc.Active, not recruitingIgA NephropathyKorea, Republic of, United States, United Kingdom
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Boston Scientific CorporationCompletedUrinary IncontinenceUnited States
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University of Southern CaliforniaCompleted
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University of Southern CaliforniaWithdrawn
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Boston Scientific CorporationCompletedOveractive BladderUnited States
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University of Southern CaliforniaCompleted
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Boston Scientific CorporationCompletedChronic, Medically Refractory HeadacheUnited States