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The study was early terminated prior to part 2 because of slow accrual.
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This study evaluates ADCT-402 in participants with relapsed or refractory B-cell lineage acute lymphoblastic leukemia (B-ALL). Participants will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In Part 2, participants will receive the dose level identified in Part 1.
Study ADCT-402-102 is the first clinical study with ADCT-402 in participants with B-cell lineage acute lymphoblastic leukemia (B-ALL).
ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated via a valine-alanine cleavable, maleimide linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin.
The study will be conducted in 2 parts. In Part 1 (dose escalation) participants will receive an infusion of ADCT-402 either on weekly administration or every 3-week administration. participants on weekly administration will receive an infusion of ADCT-402 on Days 1, 8, and 15 of each 3 week treatment cycle. Participants on 3-week administration will receive an infusion of ADCT-402 on Day 1, every 3 weeks. Dose escalation will continue until the maximum tolerated dose (MTD) is determined.
In Part 2 (expansion), all participants will be assigned to the recommended dose and/or schedule of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee.
For each patient, the study will include a screening period (up to 28 days), a treatment period (until withdrawal), 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 patient tolerability to the study drug and response to treatment. It is anticipated that the duration of the entire study (Parts 1 and 2) could be approximately 3 years from first patient treated to last patient completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ADCT-402 dose escalation | Experimental | Weekly administration - Participants will receive an intravenous (IV) infusion of ADCT-402, on Days 1, 8, and 15 of each 3-week (21-day) cycle. 3-week administration - Participants will receive an IV infusion of ADCT-402, 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-402 expansion | Experimental | All participants will be assigned to the recommended dose and/or schedule of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADCT-402 | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | 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 End of Cycle 1 (3 weeks) |
| Recommended Dose of ADCT-402 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 End of Cycle 1 (3 weeks) |
| Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any 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. | From first dose of study drug up to 12 weeks after last dose (up to 39 weeks) |
| Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment-emergent AE (TEAE) is defined as any 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the number of participants with a best overall response of complete response (CR), complete response with incomplete blood count recovery (Cri) or partial response (PR) at the time each participant discontinues treatment with ADCT-402. CR is defined as achieving each of the following:
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 is defined as achieving each of the following:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| Smilow Cancer Hospital at Yale-New Haven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32012214 | Derived | Jain N, Stock W, Zeidan A, Atallah E, McCloskey J, Heffner L, Tomlinson B, Bhatnagar B, Feingold J, Ungar D, Chao G, Zhang X, Qin Y, Havenith K, Kantarjian H, Wieduwilt MJ. Loncastuximab tesirine, an anti-CD19 antibody-drug conjugate, in relapsed/refractory B-cell acute lymphoblastic leukemia. Blood Adv. 2020 Feb 11;4(3):449-457. doi: 10.1182/bloodadvances.2019000767. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 15 μg/kg Q3W | Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| FG001 | 30 μg/kg Q3W | Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| 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 | Apr 19, 2017 | Jun 28, 2019 |
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| From first dose of study drug up to 12 weeks after last dose (up to 39 weeks) |
| From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
| Duration of Response | Duration of response is defined among responders (complete response [CR], complete response with incomplete blood count recovery [Cri], and 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. Disease progression is defined as:
| From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
| Overall Survival | Overall survival is defined as the time from the first dose of study drug treatment until the date of death due to any cause. | From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
| Progression-free Survival | Progression-free survival is defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause. | From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
| Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W) | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW) | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W) | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW) | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W) | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW) | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W) | AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Weekly (QW) | AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W) | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW) | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W) | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Accumulation Index (AI) for ADCT-402 Administered Weekly (QW) | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Volume of Distribution at Steady State for ADCT-402 | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Mean Residence Time for ADCT-402 | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Terminal Elimination Phase Rate Constant for ADCT-402 | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W) | T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW) | T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W) | Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW) | Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W) | Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW) | Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402 | Blood serum samples were collected and analysed to determine the presence or absence of ADA. | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| University Hospital of Cleveland | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Wexner Medical Center, James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Froedtert Hospital & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG002 | 60 μg/kg Q3W | Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| FG003 | 90 μg/kg Q3W | Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| FG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| FG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| FG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 15 μg/kg Q3W | Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| BG001 | 30 μg/kg Q3W | Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| BG002 | 60 μg/kg Q3W | Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| BG003 | 90 μg/kg Q3W | Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| BG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| BG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| BG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the QW dosing was based on the safety and tolerability of participants who have been treated on the every 3-week (Q3W) schedule. |
| BG007 | 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, 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 | Count of Participants | Participants |
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| Height | Height data was not collected for 3 participants 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 calculated for 3 participants due to missing height information. | Mean | Standard Deviation | kg/m^2 |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status is graded from 0 (fully active and able to carry on all pre-disease performance without restriction) to 5 (dead). | Mean | Standard Deviation | Score on a scale |
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| 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 (DLTs) | 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:
| Safety analysis set | Posted | Count of Participants | Participants | Day 1 to End of Cycle 1 (3 weeks) |
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| Primary | Recommended Dose of ADCT-402 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. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Day 1 to End of Cycle 1 (3 weeks) |
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| Primary | Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any 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. | Safety analysis set | Posted | Count of Participants | Participants | From first dose of study drug up to 12 weeks after last dose (up to 39 weeks) |
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| Primary | Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment-emergent AE (TEAE) is defined as any 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. 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. | Posted | Count of Participants | Participants | From first dose of study drug up to 12 weeks after last dose (up to 39 weeks) |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the number of participants with a best overall response of complete response (CR), complete response with incomplete blood count recovery (Cri) or partial response (PR) at the time each participant discontinues treatment with ADCT-402. CR is defined as achieving each of the following:
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 is defined as achieving each of the following:
| This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
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| Secondary | Duration of Response | Duration of response is defined among responders (complete response [CR], complete response with incomplete blood count recovery [Cri], and 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. Disease progression is defined as:
| This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
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| Secondary | Overall Survival | Overall survival is defined as the time from the first dose of study drug treatment until the date of death due to any cause. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
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| Secondary | Progression-free Survival | Progression-free survival is defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause. | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W) | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | µg/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW) | Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | µg/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
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| Secondary | Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W) | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | days | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
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| Secondary | Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW) | Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | days | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
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| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W) | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | day*ug/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW) | AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | day*ug/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W) | AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | day*ug/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Weekly (QW) | AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | day*ug/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W) | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | day*ug/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW) | AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | day*ug/L | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W) | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | ratio | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Accumulation Index (AI) for ADCT-402 Administered Weekly (QW) | AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | ratio | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady State for ADCT-402 | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Residence Time for ADCT-402 | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Phase Rate Constant for ADCT-402 | This analysis was planned, but data was not collected as the study was terminated prematurely. | Posted | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W) | T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | days | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW) | T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | days | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W) | Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | L/day | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW) | Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | L/day | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W) | Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | liters | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW) | Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. | Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed. | Posted | Mean | Standard Deviation | liters | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402 | Blood serum samples were collected and analysed to determine the presence or absence of ADA. | Posted | Count of Participants | Participants | Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2 |
|
|
From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)
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 | 15 μg/kg Q3W | Participants received 15 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. | 5 | 5 | 5 | 5 | 5 | 5 |
| EG001 | 30 μg/kg Q3W | Participants received 30 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. | 5 | 7 | 4 | 7 | 7 | 7 |
| EG002 | 60 μg/kg Q3W | Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. | 3 | 3 | 2 | 3 | 3 | 3 |
| EG003 | 90 μg/kg Q3W | Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. | 3 | 4 | 3 | 4 | 4 | 4 |
| EG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. | 3 | 5 | 5 | 5 | 5 | 5 |
| EG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. | 6 | 6 | 5 | 6 | 6 | 6 |
| EG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. | 3 | 5 | 4 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blast cells present | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angina bullosa haemorrhagica | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Amylase decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspergillus test positive | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lipase decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
|
The study was early terminated prior to part 2 because of slow accrual. Formal assessment of potential anti-leukemic effect was not undertaken because of the early termination of the study.
PI can publish after first multi-site publication, or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on the PI is the sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period that is more than 60 but less than or equal to 180 days from the time submitted to sponsor for review. The sponsor can't require changes to the communication and can't extend the embargo.
| 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 | Apr 19, 2017 | Jun 28, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000710749 | loncastuximab tesirine |
Not provided
Not provided
Not provided
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| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
|
| OG003 |
| 90 μg/kg Q3W |
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
|
| OG002 | 60 μg/kg Q3W | Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG003 | 90 μg/kg Q3W | Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
Participants received 60 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
| OG003 | 90 μg/kg Q3W | Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
| 120 μg/kg Q3W |
Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
| 90 μg/kg Q3W |
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG006 | 50 μg/kg QW | Participants received 50 μg/kg ADCT-402 weekly on Days 1, 8 and 15 of each 3-week (21-day) treatment cycle. This dose level for the weekly (QW) dosing schedule was based on the safety and tolerability of participants who had been treated on the every 3-week (Q3W) schedule. |
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
|
|
|
Participants received 90 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle.
| OG004 | 120 μg/kg Q3W | Participants received 120 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
| OG005 | 150 μg/kg Q3W | Participants received 150 μg/kg ADCT-402 on Day 1 of each 3-week treatment cycle. |
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