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Slow enrollment
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This study evaluates ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). Participants will participate in a dose-escalation phase (Part 1) and receive ADCT-301 either weekly or once every 3 weeks.
In Part 2 of the study, participants will receive a recommended dose of ADCT-301 as determined by a Dose Escalation Steering Committee.
This is a Phase 1 study with ADCT-301 to evaluate the safety, tolerability and pharmacokinetics of ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).
ADCT-301 is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication.
The study will be conducted in 2 parts: In Part 1 (dose escalation) participants will either be on weekly administration or every 3-week administration. Participants on weekly administration will receive an infusion of ADCT-301 on Days 1, 8, and 15 of each 3 week treatment cycle. Participants on 3-week administration will receive an infusion of ADCT-301 on Day 1, every 3 weeks. Dose escalation will continue until the maximum tolerated dose (MTD) is determined.
In Part 2 (expansion), participants will be assigned to receive a recommended dose and/or schedule of ADCT-301 as determined by a Dose Escalation Steering Committee.
For each participant, the study will include a screening period (up to 28 days), a treatment period, and a follow-up period to assess disease progression and survival for up to 12 months after the last dose of study drug. The total study duration will be dependent on overall participant tolerability to the study drug and response to treatment. It is anticipated that the entire study (Parts 1 and 2) will enroll a maximum of 80 participants and could last approximately 3 years from first participant treated to last participant completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ADCT-301 (dose escalation) | Experimental | Weekly administration - Participants will receive an IV infusion of ADCT-301, on Days 1, 8, and 15 of each 3-week (21-day) cycle. 3-week administration - Participants will receive an IV infusion of ADCT-301, on Day 1 of each 3-week (21-day) cycle. The dose escalation will be conducted according to a 3+3 design. |
|
| Part 2: ADCT-301 (dose expansion) | Experimental | Participants will be assigned to receive the recommended dose and/or schedule of ADCT-301 as determined by the Dose Escalation Steering Committee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADCT-301 | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLT) | A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: - Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with <5% blasts). In case of a normocellular bone marrow with <5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT. A non-hematologic DLT is defined as:
| Day 1 to Day 21 (Cycle 1) |
| Recommended Dose of ADCT-301 for Part 2 | The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study. | Day 1 to Day 21 (Cycle 1) |
| Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | A TEAE is defined as any adverse event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. | Day 1 to a maximum of 24 weeks (+ 30 days) |
| Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAE) | An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Hospitalization for elective procedures or for protocol compliance is not considered an SAE. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined among responders (complete response [CR], CR with incomplete blood count recover [CRi], or partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. CR:
CRi is defined as achieving all CR criteria except that values for ANC may be <1.0 x 10^9/L and/or values for platelets may be <100 x 10^9/L. PR:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Goldberg, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States | ||
| Northside Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32521310 | Derived | Goldberg AD, Atallah E, Rizzieri D, Walter RB, Chung KY, Spira A, Stock W, Tallman MS, Cruz HG, Boni J, Havenith KEG, Chao G, Feingold JM, Wuerthner J, Solh M. Camidanlumab tesirine, an antibody-drug conjugate, in relapsed/refractory CD25-positive acute myeloid leukemia or acute lymphoblastic leukemia: A phase I study. Leuk Res. 2020 Aug;95:106385. doi: 10.1016/j.leukres.2020.106385. Epub 2020 Jun 7. |
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Participants were enrolled at 11 sites in the United States between 01 February 2016 and 29 August 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 3 μg/kg Q3W | Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| FG001 | Cohort 2: 6 μg/kg Q3W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2018 | Feb 12, 2020 |
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| Day 1 to a maximum of 24 weeks (+ 30 days) |
| Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of CR, CRi, or PR at the time each participant discontinues treatment with ADCT-301. A summary of antitumor activity was not conducted due to a limited number of responders. | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
| Overall Survival (OS) | OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
| Number of Participants With Progression Free Survival (PFS) | PFS is defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
| Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohorts. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the Q3W Dosing Schedule | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the QW Dosing Schedule | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the Q3W Dosing Schedule | AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the QW Dosing Schedule | AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Accumulation Index (AI) for ADCT-301 for the Q3W Dosing Schedule | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Accumulation Index (AI) for ADCT-301 for the QW Dosing Schedule | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 7 days divided by AUC from 7 to 14 days for Cycle 1. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule | Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Volume of Distribution at Steady-state (Vss) for ADCT-301 for the QW Dosing Schedule | Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Mean Residence Time (MRT) for ADCT-301 for the Q3W Dosing Schedule | MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Mean Residence Time (MRT) for ADCT-301 for the QW Dosing Schedule | MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Terminal Elimination Phase Rate Constant (λz) for ADCT-301 for the Q3W Dosing Schedule | λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Terminal Elimination Phase Rate Constant (λz) for ADCT-301 for the QW Dosing Schedule | λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule | Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the QW Dosing Schedule | Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule | CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| Clearance (CL) for ADCT-301 for the QW Dosing Schedule | CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
| Number of Participants With Anti-drug Antibody Response (Against ADCT-301) | Blood serum samples were collected and analysed to determine the presence or absence of ADA. Results were pooled for Part 1 participants as specified in the protocol. | Day 1 to the end of Cycle 2 (6 weeks) |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60647 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Greenville Health System, Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | United States |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| University of Washington Medical Center | Seattle | Washington | 98109 | United States |
| Froedtert Hospital/ Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
| FG002 | Cohort 3: 12 μg/kg Q3W | Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| FG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| FG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle. |
| FG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| FG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| FG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| FG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| FG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: 3 μg/kg Q3W | Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG001 | Cohort 2: 6 μg/kg Q3W | Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG002 | Cohort 3: 12 μg/kg Q3W | Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| BG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| BG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Height data was not collected for one participant because of complications during the collection of baseline measurements. | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | BMI could not be analyzed for one participant because height data was not collected. | Mean | Standard Deviation | kg/m^2 |
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| Eastern Cooperative Oncology Group (ECOG) performance status | ECOG performance status is graded from 0 to 5: 0: Fully active, able to carry on all predisease performance without restriction.
| Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLT) | A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: - Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with <5% blasts). In case of a normocellular bone marrow with <5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT. A non-hematologic DLT is defined as:
| Posted | Count of Participants | Participants | Day 1 to Day 21 (Cycle 1) |
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| Primary | Recommended Dose of ADCT-301 for Part 2 | The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study. | The analysis was planned, but the data was not collected as study was terminated prematurely. | Posted | Day 1 to Day 21 (Cycle 1) |
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| Primary | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | A TEAE is defined as any adverse event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. | Posted | Count of Participants | Participants | Day 1 to a maximum of 24 weeks (+ 30 days) |
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| Primary | Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAE) | An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Hospitalization for elective procedures or for protocol compliance is not considered an SAE. | Posted | Count of Participants | Participants | Day 1 to a maximum of 24 weeks (+ 30 days) |
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| Secondary | Duration of Response (DOR) | DOR is defined among responders (complete response [CR], CR with incomplete blood count recover [CRi], or partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. CR:
CRi is defined as achieving all CR criteria except that values for ANC may be <1.0 x 10^9/L and/or values for platelets may be <100 x 10^9/L. PR:
| The analysis was planned, but the data was not collected as study was terminated prematurely. | Posted | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of CR, CRi, or PR at the time each participant discontinues treatment with ADCT-301. A summary of antitumor activity was not conducted due to a limited number of responders. | The analysis was planned, but the data was not collected as study was terminated prematurely. | Posted | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. | The analysis was planned, but the data was not collected as study was terminated prematurely. | Posted | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
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| Secondary | Number of Participants With Progression Free Survival (PFS) | PFS is defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders. | The analysis was planned, but the data was not collected as study was terminated prematurely. | Posted | Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*μg/L | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*μg/L | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the Q3W Dosing Schedule | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*μg/L | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the QW Dosing Schedule | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | The analysis was planned, but the data was not collected as study was terminated prematurely. | Posted | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the Q3W Dosing Schedule | AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*μg/L | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the QW Dosing Schedule | AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*μg/L | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Index (AI) for ADCT-301 for the Q3W Dosing Schedule | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Index (AI) for ADCT-301 for the QW Dosing Schedule | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 7 days divided by AUC from 7 to 14 days for Cycle 1. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
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| Secondary | Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule | Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady-state (Vss) for ADCT-301 for the QW Dosing Schedule | Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
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| Secondary | Mean Residence Time (MRT) for ADCT-301 for the Q3W Dosing Schedule | MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Residence Time (MRT) for ADCT-301 for the QW Dosing Schedule | MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Phase Rate Constant (λz) for ADCT-301 for the Q3W Dosing Schedule | λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Phase Rate Constant (λz) for ADCT-301 for the QW Dosing Schedule | λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule | Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the QW Dosing Schedule | Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
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| Secondary | Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule | CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/day | Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) for ADCT-301 for the QW Dosing Schedule | CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/day | Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days) |
|
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| Secondary | Number of Participants With Anti-drug Antibody Response (Against ADCT-301) | Blood serum samples were collected and analysed to determine the presence or absence of ADA. Results were pooled for Part 1 participants as specified in the protocol. | Posted | Count of Participants | Participants | Day 1 to the end of Cycle 2 (6 weeks) |
|
|
Day 1 to a maximum of 24 weeks (+ 30 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: 3 μg/kg Q3W | Participants received 3 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 4 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Cohort 2: 6 μg/kg Q3W | Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 3 | 3 | 1 | 3 | 2 | 3 |
| EG002 | Cohort 3: 12 μg/kg Q3W | Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 3 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 3 | 3 | 3 | 3 | 3 | 3 |
| EG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 2 | 3 | 1 | 3 | 3 | 3 |
| EG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 2 | 3 | 2 | 3 | 3 | 3 |
| EG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 2 | 3 | 2 | 3 | 3 | 3 |
| EG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). | 1 | 4 | 2 | 4 | 4 | 4 |
| EG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. | 5 | 6 | 5 | 6 | 6 | 6 |
| EG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. | 2 | 3 | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intra-abdominal Haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac Chest Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Streptococcal Bacteraemia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ocular Hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pupillary Reflex Impaired | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lip Ulceration | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oral Mucosa Haematoma | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tongue Coated | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac Chest Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Graft versus Host Disease | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Anorectal Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Enterococcus Test Positive | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Troponin I Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Autonomic Nervous System Imbalance | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sinus Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cold Sweat | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypersensitivity Vasculitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin Mass | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Capillary Leak Syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphoedema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
Only a small number of participants were analyzed as the study was early terminated due to slow enrollment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ADC Therapeutics | ADC Therapeutics | 954-903-7994 | clinical.trials@adctherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2018 | Feb 12, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| OG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
|
|
Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| OG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
|
|
Participants received 6 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
| OG002 | Cohort 3: 12 μg/kg Q3W | Participants received 12 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| OG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
|
Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| OG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
|
Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| OG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
|
Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG008 | Cohort 9: 30 μg/kg QW | Participants received 30 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
| OG009 | Cohort 10: 37.5 μg/kg QW | Participants received 37.5 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Days 1, 8 and 15 (once weekly [QW]) of each 3-week (21 day) cycle. |
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
|
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
|
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
| Participants |
|
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
| Participants |
|
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
| Counts |
|---|
| Participants |
|
|
| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
|
|
|
|
Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
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Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W).
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
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| OG003 | Cohort 4: 22 μg/kg Q3W | Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
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| OG003 |
| Cohort 4: 22 μg/kg Q3W |
Participants received 22 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG004 | Cohort 5: 32 μg/kg Q3W | Participants received 32 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG005 | Cohort 6: 52 μg/kg Q3W | Participants received 52 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG006 | Cohort 7: 72 μg/kg Q3W | Participants received 72 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
| OG007 | Cohort 8: 92 μg/kg Q3W | Participants received 92 μg/kg ADCT-301 formulation, intravenous infusion for 1 hour, on Day 1 of each 3-week (21-day) cycle (Q3W). |
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