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

Primary Purpose

Multiple Myeloma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BION-1301

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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

Sites / Locations

James R. Berenson, MD, Inc
Winship Cancer Institute/Emory University
Ohio State University Wexner Medical Center James Cancer Hospital
UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center
Virginia Cancer Specialists
Swedish Medical Center
Froedtert Hospital & The Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BION-1301

Arm Description

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

Outcomes

Primary Outcome Measures

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

Recommended Phase 2 Dose (Phase 1)

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

Biomarkers (Phase 1 and 2)

Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)

Bioanalytical Measures (Phase 1 and Phase 2)

Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline

Safety Profile (Phase 2)

BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities

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)

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03340883

First Posted

November 3, 2017

Last Updated

March 8, 2021

Sponsor

Chinook Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03340883

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

No objective responses observed following completion of Phase 1 dose-escalation

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

June 13, 2019 (Actual)

Study Completion Date

July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chinook Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Single arm study

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BION-1301

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

BION-1301

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety (Phase 1)

Description

Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent

Time Frame

28 days following first administration of BION-1301

Title

Recommended Phase 2 Dose (Phase 1)

Description

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

Time Frame

Approximately 2 years

Title

Biomarkers (Phase 1 and 2)

Description

Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)

Time Frame

Baseline and approximately 2 years

Title

Bioanalytical Measures (Phase 1 and Phase 2)

Description

Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline

Time Frame

Baseline and approximately 2 years

Title

Safety Profile (Phase 2)

Description

BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities

Time Frame

28 days

Title

Response Rate (Phase 2)

Description

Time Frame

Approximately 30 months

Title

Progression-Free Survival (Phase 2)

Description

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

Time Frame

Approximately 30 months

Title

Overall Survival (Phase 2)

Description

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

Time Frame

Approximately 30 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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. Key Exclusion Criteria: 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

Facility Information:

Facility Name

James R. Berenson, MD, Inc

City

West Hollywood

State/Province

California

ZIP/Postal Code

90069

Country

United States

Facility Name

Winship Cancer Institute/Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Ohio State University Wexner Medical Center James Cancer Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Virginia Cancer Specialists

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Froedtert Hospital & The Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21292775

Citation

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.

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

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