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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:November 15, 2017
End Date:June 2020

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A Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma

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).

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
We found this trial at
7
sites
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: William Bensinger, MD
Phone: 206-386-2831
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Ajay Nooka, MD
Phone: 404-778-5714
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Columbus, Ohio 43210
Principal Investigator: Maria Chaudry, MD
Phone: 614-293-9273
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alexander Spira, MD, PhD
Phone: 571-389-0873
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Milwaukee, Wisconsin
Principal Investigator: Parameswaran Hari, MD
Phone: 866-680-0505
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Milwaukee, WI
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Anastasios Raptis, MD, PhD
Phone: 412-647-8571
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Pittsburgh, PA
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West Hollywood, California 90069
Principal Investigator: James R Berenson, MD
Phone: 310-623-1227
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West Hollywood, CA
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