A Phase 1/2 interventional study of BION-1301 in Multiple Myeloma, sponsored by Chinook Therapeutics, Inc.. Terminated at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Chinook Therapeutics, Inc. (part of Novartis) · Phase 1/2, Interventional, and Treatment
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).
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 21 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Chinook Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
First submitted before Chinook Therapeutics, Inc. became part of Novartis.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol:
as defined by one or more of the following:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Approximately 30 months
Subject enrollment was stopped prematurely due to the sponsor's decision to terminate the study. Therefore, the study did not proceed to the Phase 2 portion of the study protocol. All reporting groups are for Phase 1 only.
| Milestone | BION-1301 50 mg Q2W | BION-1301 150 mg Q2W | BION-1301 450 mg Q2W | BION-1301 1350 mg Q2W | BION-1301 2700 mg Q2W | BION-1301 1350 mg QW*8W->Q2W |
|---|---|---|---|---|---|---|
| Started | 4 | 3 | 4 | 4 | 3 | 3 |
| Completed | 4 | 3 | 4 | 4 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
| Participants | BION-1301 50 mg Q2W | BION-1301 150 mg Q2W | BION-1301 450 mg Q2W | BION-1301 1350 mg Q2W | BION-1301 2700 mg Q2W | BION-1301 1350 mg QW*8W->Q2W |
|---|---|---|---|---|---|---|
| Safety (Phase 1) | 0 | 0 | 0 | 1 | 0 | 0 |
Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent
No measurements were reported for this outcome.
Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
| % change relative to baseline | BION-1301 50 mg Q2W | BION-1301 150 mg Q2W | BION-1301 450 mg Q2W | BION-1301 1350 mg Q2W | BION-1301 2700 mg Q2W | BION-1301 1350 mg QW*8W->Q2W |
|---|---|---|---|---|---|---|
| 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) |
Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline
| percentage change | BION-1301 50 mg Q2W | BION-1301 150 mg Q2W | BION-1301 450 mg Q2W | BION-1301 1350 mg Q2W | BION-1301 2700 mg Q2W | BION-1301 1350 mg QW*8W->Q2W |
|---|---|---|---|---|---|---|
| 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) | 20.125 (14.888 to 25.362) | — | 0.352 (0.352 to 0.352) |
| Serum Immunoglobulin M (g/L) | 27.273 (27.273 to 76.563) | 28.571 (14.286 to 40.000) | 40.000 (40.000 to 40.000) | 61.364 (54.545 to 68.182) | 64.148 (46.154 to 82.143) | — |
| Serum Kappa Light Chain, Free (mg/dL) | 34.0000 (6.7568 to 46.4419) | 5.9735 (5.9735 to 5.9735) | 42.0349 (30.0000 to 54.0698) | 72.4863 (69.3627 to 75.6098) | 64.8649 (64.8649 to 64.8649) | 47.9787 (30.0000 to 65.9574) |
| Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) | 53.919 (50.000 to 57.838) | — | 50.000 (50.000 to 50.000) | 100.000 (100.000 to 100.000) | 60.000 (60.000 to 60.000) | 100.000 (100.000 to 100.000) |
| Serum Lambda Light Chain, Free (mg/dL) | 13.9651 (7.0000 to 20.9302) | 26.3520 (11.1111 to 41.5929) | 13.4372 (13.4028 to 57.6642) | 26.9335 (12.5000 to 41.3669) | 24.5619 (20.0000 to 29.1237) | — |
| Serum Monoclonal Protein Spike (g/dL) | 13.1579 (1.0526 to 50.0000) | — | 5.4670 (5.4670 to 5.4670) | 27.2727 (27.2727 to 27.2727) | — | — |
| Serum Protein (g/dL) | 8.14 (8.14 to 8.14) | — | 3.06 (2.88 to 3.23) | 3.03 (3.03 to 3.03) | 6.74 (6.74 to 6.74) | 3.05 (1.69 to 4.41) |
| Urine Albumin (mg/dL) | — | 18.1818 (18.1818 to 18.1818) | — | — | 54.7349 (20.6055 to 88.8643) | — |
| Urine Alpha-1 Globulin (mg/dL) | — | 80.0000 (80.0000 to 80.0000) | — | — | 71.7418 (60.4982 to 82.9854) | — |
| Urine Alpha-2 Globulin (mg/dL) | — | — | — | — | 63.5621 (37.2727 to 89.8515) | — |
| Urine Beta Globulin (mg/dL) | — | — | — | 19.4996 (19.4996 to 19.4996) | 49.3411 (6.6748 to 92.0074) | — |
| Urine Gamma Globulin (mg/dL) | — | 90.3185 (90.3185 to 90.3185) | 100.0000 (100.0000 to 100.0000) | — | 93.1735 (93.1735 to 93.1735) | — |
| Urine Monoclonal Protein Spike (%) | — | — | — | 2.755 (2.755 to 2.755) | 30.695 (30.695 to 30.695) | 11.819 (11.819 to 11.819) |
| Urine Protein (mg/dL) | — | — | — | — | 52.9665 (14.2857 to 91.6472) | — |
| Urine Protein, Calculated (mg/24hr) | — | — | 9.1743 (9.1743 to 9.1743) | — | 42.9298 (15.0943 to 70.7652) | — |
BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BION-1301 50 mg Q2W | 1/4 (25%) | 3/4 (75%) | 4/4 (100%) |
| BION-1301 150 mg Q2W | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| BION-1301 450 mg Q2W | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| BION-1301 1350 mg Q2W | 2/4 (50%) | 2/4 (50%) | 3/4 (75%) |
| BION-1301 2700 mg Q2W | 1/3 (33.3%) | 0/3 (0%) | 2/3 (66.7%) |
| BION-1301 1350 mg QW*8W->Q2W | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | BION-1301 50 mg Q2W | BION-1301 150 mg Q2W | BION-1301 450 mg Q2W | BION-1301 1350 mg Q2W | BION-1301 2700 mg Q2W | BION-1301 1350 mg QW*8W->Q2W |
|---|---|---|---|---|---|---|
| HypercalcaemiaMetabolism and nutrition disorders | 0/4 | 1/3 | 1/4 | 0/4 | 0/3 | 1/3 |
| AstheniaGeneral disorders | 0/4 | 0/3 | 1/4 | 0/4 | 0/3 | 0/3 |
| Sudden deathGeneral disorders | 1/4 | 0/3 | 0/4 | 0/4 | 0/3 | 0/3 |
| Lung infectionInfections and infestations | 0/4 | 0/3 | 0/4 | 1/4 | 0/3 | 0/3 |
| Staphylococcal sepsisInfections and infestations | 1/4 | 0/3 | 0/4 | 0/4 | 0/3 | 0/3 |
| Acute kidney injuryRenal and urinary disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/3 | 0/3 |
| Renal failureRenal and urinary disorders | 0/4 | 0/3 | 1/4 | 0/4 | 0/3 | 0/3 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/3 | 0/3 |
| WheezingRespiratory, thoracic and mediastinal disorders | 1/4 | 0/3 | 0/4 | 0/4 | 0/3 | 0/3 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/4 | 0/3 | 0/4 | 1/4 | 0/3 | 0/3 |
| Event | BION-1301 50 mg Q2W | BION-1301 150 mg Q2W | BION-1301 450 mg Q2W | BION-1301 1350 mg Q2W | BION-1301 2700 mg Q2W | BION-1301 1350 mg QW*8W->Q2W |
|---|---|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 3/4 | 0/3 | 0/4 | 0/4 | 0/3 | 0/3 |
| FatigueGeneral disorders | 1/4 | 0/3 | 0/4 | 3/4 | 0/3 | 0/3 |
| Back painMusculoskeletal and connective tissue disorders | 0/4 | 1/3 | 0/4 | 1/4 | 0/3 | 2/3 |
| Decreased appetiteMetabolism and nutrition disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/3 | 2/3 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/4 | 0/3 | 0/4 | 2/4 | 1/3 | 0/3 |
| HyperuricaemiaMetabolism and nutrition disorders | 1/4 | 0/3 | 0/4 | 2/4 | 0/3 | 0/3 |
| HyperkalaemiaMetabolism and nutrition disorders | 0/4 | 0/3 | 0/4 | 2/4 | 0/3 | 0/3 |
| AnaemiaBlood and lymphatic system disorders | 1/4 | 0/3 | 1/4 | 2/4 | 0/3 | 1/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/4 | 0/3 | 0/4 | 2/4 | 0/3 | 0/3 |
| HypertensionVascular disorders | 0/4 | 0/3 | 0/4 | 2/4 | 1/3 | 1/3 |
All participants who received at least one dose of study drug.
| Age, Customized(Participants) | Phase 1 BION-1301 |
|---|---|
| <65 years | 6 |
| >=65 years | 15 |
| Sex: Female, Male(Participants) | Phase 1 BION-1301 |
|---|---|
| Female | 9 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1 BION-1301 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Phase 1 BION-1301 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zigakibart