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

March 8, 2021 updated by: Chinook Therapeutics, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Hollywood, California, United States, 90069
        • James R. Berenson, MD, Inc
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute/Emory University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center James Cancer Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
28 days following first administration of BION-1301
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
Approximately 2 years
Biomarkers (Phase 1 and 2)
Time Frame: Baseline and approximately 2 years
Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
Baseline and approximately 2 years
Bioanalytical Measures (Phase 1 and Phase 2)
Time Frame: Baseline and approximately 2 years
Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline
Baseline and approximately 2 years
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
28 days
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)
Approximately 30 months
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
Approximately 30 months
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
Approximately 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinook Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2017

Primary Completion (ACTUAL)

June 13, 2019

Study Completion (ACTUAL)

July 9, 2019

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (ACTUAL)

November 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADU-CL-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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