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Trial record 1 of 2 for:    BION-1301
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Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03340883
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : May 10, 2019
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 14, 2017
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE November 15, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Safety (Phase 1) [ Time Frame: 28 days following first administration of BION-1301 ]
    Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
  • Recommended Phase 2 Dose (Phase 1) [ Time Frame: Approximately 2 years ]
    Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent
  • Biomarkers (Phase 1 and 2 ) [ Time Frame: Approximately 2 years ]
    Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
  • Bioanalytical measures (Phase 1 and 2) [ Time Frame: Approximately 2 years ]
    Relative reduction in serum and urine M-protein levels defined as the maximum reduction from baseline
  • Safety Profile (Phase 2) [ Time Frame: 28 days ]
    BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities
  • Response Rate (Phase 2) [ Time Frame: Approximately 30 months ]
    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)
  • Progression-Free Survival (Phase 2) [ Time Frame: Approximately 30 months ]
    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
  • Overall Survival (Phase 2) [ Time Frame: Approximately 30 months ]
    Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03340883 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)
Official Title  ICMJE A Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Biological: BION-1301
a solution for intravenous (IV) administration, diluted and administered Q2W
Study Arms  ICMJE Experimental: BION-1301
BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
Intervention: Biological: BION-1301
Publications * Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, Avet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San Miguel J; International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

Individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol:

  1. Male or female, aged ≥ 18 years
  2. Confirmed diagnosis of MM per IMWG criteria
  3. 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
  4. 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.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  6. Adequate organ and marrow function at Screening, as defined by the study protocol.

Key Exclusion Criteria:

  1. Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenstrom's macroglobulinemia, or IgM myeloma
  2. Active plasma cell leukemia (˃ 2.0 × 109/L circulating plasma cells by standard differential)
  3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  4. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03340883
Other Study ID Numbers  ICMJE ADU-CL-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aduro Biotech, Inc.
Study Sponsor  ICMJE Aduro Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aduro Biotech, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP