Multiple Myeloma
Conditions
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).
Interventions
BIOLOGICALBION-1301
a solution for intravenous (IV) administration, diluted and administered Q2W
Sponsors
Chinook Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Phase 1) | 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) | Approximately 2 years | Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent |
| Biomarkers (Phase 1 and 2) | 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) | 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) | 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) | 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) | 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) | Approximately 30 months | Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 BION-1301 BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
BION-1301: a solution for intravenous (IV) administration, diluted and administered Q2W | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Phase 1 BION-1301 |
|---|---|
| Age, Customized <65 years | 6 Participants |
| Age, Customized >=65 years | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 2 / 3 | 0 / 4 | 2 / 4 | 1 / 3 | 1 / 3 |
| other Total, other adverse events | 4 / 4 | 3 / 3 | 4 / 4 | 3 / 4 | 2 / 3 | 3 / 3 |
| serious Total, serious adverse events | 3 / 4 | 1 / 3 | 1 / 4 | 2 / 4 | 0 / 3 | 1 / 3 |
Outcome results
Primary
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
Population: Some laboratory tests were not performed for some of the participants. Therefore, the number analyzed does not always match the overall number of participants analyzed. Study was terminated early and Phase 2 did not enroll.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum A/G Ratio (RATIO) | 24.763 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Albumin (g/dL) | 40.191 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-1 Globulin (g/dL) | 18.698 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-2 Globulin (g/dL) | 2.985 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Beta Globulin (g/dL) | 33.636 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Gamma Globulin (g/dL) | 13.920 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin A (g/L) | 1.615 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin G (g/L) | 25.274 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin M (g/L) | 27.273 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa Light Chain, Free (mg/dL) | 34.0000 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) | 53.919 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Lambda Light Chain, Free (mg/dL) | 13.9651 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Monoclonal Protein Spike (g/dL) | 13.1579 percentage change |
| BION-1301 50 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Protein (g/dL) | 8.14 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Albumin (g/dL) | 5.405 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Beta Globulin (g/dL) | 3.125 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Alpha-1 Globulin (mg/dL) | 80.0000 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin M (g/L) | 28.571 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin A (g/L) | 66.667 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Lambda Light Chain, Free (mg/dL) | 26.3520 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-2 Globulin (g/dL) | 31.579 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Albumin (mg/dL) | 18.1818 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa Light Chain, Free (mg/dL) | 5.9735 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum A/G Ratio (RATIO) | 31.538 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin G (g/L) | 25.000 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Gamma Globulin (mg/dL) | 90.3185 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-1 Globulin (g/dL) | 30.556 percentage change |
| BION-1301 150 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Gamma Globulin (g/dL) | 96.552 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin G (g/L) | 25.016 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Albumin (g/dL) | 10.591 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Protein, Calculated (mg/24hr) | 9.1743 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin M (g/L) | 40.000 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Lambda Light Chain, Free (mg/dL) | 13.4372 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa Light Chain, Free (mg/dL) | 42.0349 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) | 50.000 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Beta Globulin (g/dL) | 0.542 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum A/G Ratio (RATIO) | 28.571 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Gamma Globulin (g/dL) | 25.926 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-2 Globulin (g/dL) | 14.286 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Gamma Globulin (mg/dL) | 100.0000 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin A (g/L) | 36.174 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-1 Globulin (g/dL) | 29.710 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Protein (g/dL) | 3.06 percentage change |
| BION-1301 450 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Monoclonal Protein Spike (g/dL) | 5.4670 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Protein (g/dL) | 3.03 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Beta Globulin (mg/dL) | 19.4996 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-2 Globulin (g/dL) | 10.843 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Beta Globulin (g/dL) | 22.472 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Gamma Globulin (g/dL) | 23.441 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin A (g/L) | 30.536 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin G (g/L) | 20.125 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Monoclonal Protein Spike (%) | 2.755 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin M (g/L) | 61.364 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa Light Chain, Free (mg/dL) | 72.4863 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) | 100.000 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Lambda Light Chain, Free (mg/dL) | 26.9335 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Monoclonal Protein Spike (g/dL) | 27.2727 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Albumin (g/dL) | 9.294 percentage change |
| BION-1301 1350 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-1 Globulin (g/dL) | 24.138 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) | 60.000 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Protein (mg/dL) | 52.9665 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Monoclonal Protein Spike (%) | 30.695 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin M (g/L) | 64.148 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Alpha-2 Globulin (mg/dL) | 63.5621 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Lambda Light Chain, Free (mg/dL) | 24.5619 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Protein (g/dL) | 6.74 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin A (g/L) | 23.077 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Albumin (mg/dL) | 54.7349 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Gamma Globulin (g/dL) | 0.627 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Beta Globulin (g/dL) | 8.571 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum A/G Ratio (RATIO) | 20.202 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Alpha-1 Globulin (mg/dL) | 71.7418 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Beta Globulin (mg/dL) | 49.3411 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Albumin (g/dL) | 3.571 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa Light Chain, Free (mg/dL) | 64.8649 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Gamma Globulin (mg/dL) | 93.1735 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-2 Globulin (g/dL) | 14.286 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Protein, Calculated (mg/24hr) | 42.9298 percentage change |
| BION-1301 2700 mg Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-1 Globulin (g/dL) | 16.129 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin G (g/L) | 0.352 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-1 Globulin (g/dL) | 20.000 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Beta Globulin (g/dL) | 2.609 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Albumin (g/dL) | 7.979 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Immunoglobulin A (g/L) | 23.077 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa Light Chain, Free (mg/dL) | 47.9787 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Urine Monoclonal Protein Spike (%) | 11.819 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Protein (g/dL) | 3.05 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO) | 100.000 percentage change |
| BION-1301 1350 mg QW*8W->Q2W | Bioanalytical Measures (Phase 1 and Phase 2) | Serum Alpha-2 Globulin (g/dL) | 10.000 percentage change |
Primary
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
Population: Study was terminated early and Phase 2 did not enroll. BCMA was an exploratory endpoint and was not reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BION-1301 50 mg Q2W | Biomarkers (Phase 1 and 2) | Free APRIL target engagement (AUEC1-15d) | 1000 % change relative to baseline |
| BION-1301 150 mg Q2W | Biomarkers (Phase 1 and 2) | Free APRIL target engagement (AUEC1-15d) | 970 % change relative to baseline |
| BION-1301 450 mg Q2W | Biomarkers (Phase 1 and 2) | Free APRIL target engagement (AUEC1-15d) | 470 % change relative to baseline |
| BION-1301 1350 mg Q2W | Biomarkers (Phase 1 and 2) | Free APRIL target engagement (AUEC1-15d) | 140 % change relative to baseline |
| BION-1301 2700 mg Q2W | Biomarkers (Phase 1 and 2) | Free APRIL target engagement (AUEC1-15d) | 72 % change relative to baseline |
| BION-1301 1350 mg QW*8W->Q2W | Biomarkers (Phase 1 and 2) | Free APRIL target engagement (AUEC1-15d) | 200 % change relative to baseline |
Primary
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
Population: Study was terminated early and Phase 2 did not enroll. Overall survival was not assessed.
Primary
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
Population: Study was terminated early and Phase 2 did not enroll. Progression-free survival was not assessed.
Primary
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
Population: Study was terminated early. No outcome measures were assessed.
Primary
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
Population: Study was terminated early and Phase 2 was not enrolled. Objective response rate was not assessed.
Primary
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
Population: Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BION-1301 50 mg Q2W | Safety (Phase 1) | 0 Participants |
| BION-1301 150 mg Q2W | Safety (Phase 1) | 0 Participants |
| BION-1301 450 mg Q2W | Safety (Phase 1) | 0 Participants |
| BION-1301 1350 mg Q2W | Safety (Phase 1) | 1 Participants |
| BION-1301 2700 mg Q2W | Safety (Phase 1) | 0 Participants |
| BION-1301 1350 mg QW*8W->Q2W | Safety (Phase 1) | 0 Participants |
Primary
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
Population: Study was terminated early and Phase 2 was not enrolled. Safety profile was not assessed.