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Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)

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ClinicalTrials.gov Identifier: NCT03340883
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Aduro Biotech, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: BION-1301 Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: BION-1301
BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
Biological: BION-1301
a solution for intravenous (IV) administration, diluted and administered Q2W




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340883


Locations
United States, California
James R. Berenson, MD, Inc Recruiting
West Hollywood, California, United States, 90069
Contact: Regina Swift    310-623-1227    Rswift@berensononcology.com   
Principal Investigator: James R Berenson, MD         
United States, Georgia
Winship Cancer Institute/Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lisa Hwang    404-778-5714    m.lisa.hwang@emory.edu   
Principal Investigator: Ajay Nooka, MD         
United States, Ohio
Ohio State University Wexner Medical Center James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Maria Chaudry, MD    614-293-9273    Maria.Chaudry@osumc.edu   
Principal Investigator: Maria Chaudry, MD         
United States, Pennsylvania
UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Rita Johnson    412-647-8571    Johnsonr1@upmc.edu   
Principal Investigator: Anastasios Raptis, MD, PhD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Karin Choquette, MSN, RN    571-389-0873      
Principal Investigator: Alexander Spira, MD, PhD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Tenzin Tsomo    206-386-2831    Tenzin.Tsomo@Swedish.org   
Principal Investigator: William Bensinger, MD         
United States, Wisconsin
Froedtert Hospital & The Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Samantha Barrington    866-680-0505 ext 8900 800#    cccto@mcw.edu   
Principal Investigator: Parameswaran Hari, MD         
Sponsors and Collaborators
Aduro Biotech, Inc.

Publications:
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03340883     History of Changes
Other Study ID Numbers: ADU-CL-16
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases