Multiple MyelomaPhase 1/2NCT03340883

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

A Phase 1/2 study testing BION-1301 in people with Multiple Myeloma, run by Chinook Therapeutics, Inc. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: BION-1301
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 7 sitesUnited States
Study dates: 15 Nov 2017to 9 Jul 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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.

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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

Read the 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).

Conditions: Multiple Myeloma
Being tested: BION-1301
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BION-1301Biological
a solution for intravenous (IV) administration, diluted and administered Q2W

Study groups in NCT03340883
Study group	Role	What they receive
BION-1301	Experimental	BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion. Receives: Biological: BION-1301

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Approximately 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20179 Jul 2019

First posted14 Nov 2017
Study start15 Nov 2017
Primary completion13 Jun 2019
Study completion9 Jul 2019

Why it stopped: No objective responses observed following completion of Phase 1 dose-escalation

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm study
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03340883
Sponsor's protocol ID: ADU-CL-16
Status last verified: Mar 2021
First submitted: 3 Nov 2017
Last updated: 1 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21292775

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT03340883
Acronym / sponsor ID: ADU-CL-16
Conditions: Multiple Myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: No objective responses observed following completion of Phase 1 dose-escalation
Enrolment: 21 participants (actual)
Lead sponsor: Chinook Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 15 Nov 2017 (actual)
Primary completion: 13 Jun 2019 (actual)
Study completion: 9 Jul 2019 (actual)
First posted: 14 Nov 2017 (actual)
Results: Posted 7 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm study

Arm	Type	Receives
BION-1301	Experimental	Biological: BION-1301BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BION-1301a solution for intravenous (IV) administration, diluted and administered Q2W	Biological	BION-1301

Primary outcome

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
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
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)
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
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
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)
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
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

Results and safety

Results posted to the registry on 7 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BION-1301 50 mg Q2W	4	4
BION-1301 150 mg Q2W	3	3
BION-1301 450 mg Q2W	4	4
BION-1301 1350 mg Q2W	4	4
BION-1301 2700 mg Q2W	3	3
BION-1301 1350 mg QW*8W->Q2W	3	3

Primary outcome: Safety (Phase 1)

Time frame: 28 days following first administration of BION-1301. Count of participants. Unit: Participants

Measure	BION-1301 50 mg Q2W n = 4	BION-1301 150 mg Q2W n = 3	BION-1301 450 mg Q2W n = 4	BION-1301 1350 mg Q2W n = 4	BION-1301 2700 mg Q2W n = 3	BION-1301 1350 mg QW*8W->Q2W n = 3
Value	0	0	0	1	0	0

Population analysed: Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study.

Primary outcome: Recommended Phase 2 Dose (Phase 1)

Time frame: Approximately 2 years

Population analysed: Study was terminated early. No outcome measures were assessed.

Primary outcome: Biomarkers (Phase 1 and 2)

Time frame: Baseline and approximately 2 years. Median (Full Range). Unit: % change relative to baseline

Measure	BION-1301 50 mg Q2W n = 4	BION-1301 150 mg Q2W n = 3	BION-1301 450 mg Q2W n = 4	BION-1301 1350 mg Q2W n = 4	BION-1301 2700 mg Q2W n = 3	BION-1301 1350 mg QW*8W->Q2W n = 3
Free APRIL target engagement (AUEC1-15d)	1000 (580 to 1500)	970 (750 to 1200)	470 (190 to 620)	140 (79 to 510)	72 (70 to 250)	200 (56 to 240)

Population analysed: Study was terminated early and Phase 2 did not enroll. BCMA was an exploratory endpoint and was not reported.

Primary outcome: Bioanalytical Measures (Phase 1 and Phase 2)

Time frame: Baseline and approximately 2 years. Median (Inter-Quartile Range). Unit: percentage change

Measure	BION-1301 50 mg Q2W n = 4	BION-1301 150 mg Q2W n = 3	BION-1301 450 mg Q2W n = 4	BION-1301 1350 mg Q2W n = 4	BION-1301 2700 mg Q2W n = 3	BION-1301 1350 mg QW*8W->Q2W n = 3
Serum A/G Ratio (RATIO)	24.763 (18.182 to 31.343)	31.538 (23.077 to 40.000)	28.571 (28.571 to 28.571)	–	20.202 (18.182 to 22.222)	–
Serum Albumin (g/dL)	40.191 (27.326 to 53.056)	5.405 (5.217 to 28.000)	10.591 (6.897 to 14.286)	9.294 (3.808 to 17.042)	3.571 (2.778 to 13.587)	7.979 (7.979 to 7.979)
Serum Alpha-1 Globulin (g/dL)	18.698 (14.815 to 22.581)	30.556 (30.556 to 30.556)	29.710 (26.087 to 33.333)	24.138 (24.138 to 24.138)	16.129 (16.129 to 16.129)	20.000 (18.919 to 50.000)
Serum Alpha-2 Globulin (g/dL)	2.985 (2.439 to 20.408)	31.579 (31.579 to 31.579)	14.286 (13.415 to 14.754)	10.843 (9.756 to 12.037)	14.286 (14.286 to 14.286)	10.000 (4.918 to 33.333)
Serum Beta Globulin (g/dL)	33.636 (33.636 to 33.636)	3.125 (3.125 to 3.125)	0.542 (0.542 to 0.542)	22.472 (22.472 to 22.472)	8.571 (7.143 to 10.000)	2.609 (2.609 to 2.609)
Serum Gamma Globulin (g/dL)	13.920 (8.511 to 41.667)	96.552 (96.552 to 96.552)	25.926 (15.789 to 50.000)	23.441 (22.807 to 24.074)	0.627 (0.627 to 0.627)	–
Serum Immunoglobulin A (g/L)	1.615 (1.615 to 1.615)	66.667 (66.667 to 66.667)	36.174 (0.717 to 71.631)	30.536 (12.500 to 48.571)	23.077 (16.667 to 70.588)	23.077 (23.077 to 23.077)
Serum Immunoglobulin G (g/L)	25.274 (8.312 to 42.236)	25.000 (16.788 to 33.212)	25.016 (22.566 to 27.467)

Adverse events

Time frame: From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 1 year from the date of randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BION-1301 50 mg Q2W	3 of 4 (75%)	4 of 4 (100%)	1 of 4
BION-1301 150 mg Q2W	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
BION-1301 450 mg Q2W	1 of 4 (25%)	4 of 4 (100%)	0 of 4
BION-1301 1350 mg Q2W	2 of 4 (50%)	3 of 4 (75%)	2 of 4
BION-1301 2700 mg Q2W	0 of 3 (0%)	2 of 3 (66.7%)	1 of 3
BION-1301 1350 mg QW*8W->Q2W	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3

Limitations and caveats (from the sponsor): ADU-CL-16 was terminated early leading to a small number of Phase 1 subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21292775Rajkumar 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BION-1301 in people with Multiple Myeloma, run by Chinook Therapeutics, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Phase 1) (time frame: 28 days following first administration of BION-1301). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03340883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.