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

NCT03340883 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: ADU-CL-16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 7

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (8)

• Safety (Phase 1)

  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)

  Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent

  Approximately 2 years

• Biomarkers (Phase 1 and 2)

  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)

  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)

  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)

  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)

  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)

  Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause

  Approximately 30 months

Study Arms (1)

BION-1301

EXPERIMENTAL

BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.

Biological: BION-1301

Interventions

BION-1301 BIOLOGICAL

a solution for intravenous (IV) administration, diluted and administered Q2W

BION-1301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinook Therapeutics, Inc.: lead

Study Sites (7)

James R. Berenson, MD, Inc

West Hollywood, California, 90069, United States

Location

Winship Cancer Institute/Emory University

Atlanta, Georgia, 30322, United States

Location

Ohio State University Wexner Medical Center James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Froedtert Hospital & The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 21292775 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

ADU-CL-16 was terminated early leading to a small number of Phase 1 subjects analyzed.

Results Point of Contact

• Title: Chinook Therapeutics, Inc. (formerly Aduro Biotech, Inc.)
• Organization: Chinook Therapeutics, Inc.

clinicaltrials@chinooktx.com

206-485-7051

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm study

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 14, 2017
• Study Start: November 15, 2017
• Primary Completion: June 13, 2019
• Study Completion: July 9, 2019
• Last Updated: April 1, 2021
• Results First Posted: September 7, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)