| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities | | | Posted | | Count of Participants | | Participants | | Day 1 to 3 Weeks (one cycle) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG004 | Part 1: Dose 180μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (180 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG005 | Part 1: Dose 210μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (210 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG006 | Part 1: Dose 240μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (240 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Number of Participants Who Experienced a Dose-Limiting Toxicity With a CTCAE Grade of 3 or Above | The Common Terminology Criteria For Adverse Events (CTCAE) Version 4 will be used. | | Posted | | Count of Participants | | Participants | | Day 1 to 3 Weeks (one cycle) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | |
|
| Primary | Number of Participants Who Experience At Least One Treatment Emergent Adverse Event (TEAE) | An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | | Posted | | Count of Participants | | Participants | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | |
|
| Primary | Number of Participants Who Experience At Least One Treatment Emergent Serious Adverse Event (SAE) | | | Posted | | Count of Participants | | Participants | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG004 | Part 1: Dose 180μg/kg |
|
| Primary | Number of Participants With Clinically Significant Clinical Laboratory Tests | Clinical significance was determined by the investigator. | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Primary | Number of Participants With Clinically Significant Physical Examination Results | Clinical significance was determined by the investigator. | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Primary | Number of Participants Who Experience a Clinically Significant Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Performance status was assessed using the ECOG performance status grades. These range between Grade 0 (fully active) and Grade 5 (dead). Clinical significance was determined by the investigator. | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg |
|
| Primary | Number of Participants With Clinically Significant Vital Signs | Vital sign measurements include arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator. | | Posted | | Count of Participants | | Participants | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Primary | Number of Participants Who Experience Clinically Significant Electrocardiogram (ECG) Results | Standard 12-lead ECG's will be used. Clinical significance was determined by the investigator. | | Posted | | Count of Participants | | Participants | | Day 1 to end of trial, a maximum of 168 days (+ 30 days) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Overall Response Rate (ORR) | ORR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR) at the time each participant discontinues ADCT-502. Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. | | Posted | | Count of Participants | | Participants | | Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | |
|
| Secondary | Disease Control Rate (DCR) | DCR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD). Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: stable disease is when the change is > -30% and ≤ 20%, partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. | | Posted | | Count of Participants | | Participants | | Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Duration of Response (DOR) | DOR was defined among responders (CR or 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. | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Progression-Free Survival (PFS) | PFS was 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 due to safety reasons. | Posted | | | | | | Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 as a 150μg/kg dose. |
|
| Secondary | Overall Survival (OS) | Median OS was defined as the time from the beginning of study drug treatment until death due to any cause. | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of ADCT-502 (Total Antibody) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Area Under the Plasma Concentration Time Curve (AUC) of Drug To-antibody Ratio [DAR] ≥0 | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of PBD-conjugated Antibody (DAR ≥1) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of Free Warhead SG3199 | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for ADCT-502 (Total Antibody) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for Drug To-antibody Ratio [DAR] ≥0 | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for PBD-conjugated Antibody (DAR ≥1) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for Free Warhead SG3199 | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) for ADCT-502 (Total Antibody) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) for Drug To-antibody Ratio [DAR] ≥0) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
|
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) for PBD-conjugated Antibody (DAR ≥1) | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
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| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) for Free Warhead SG3199 | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose | | | | ID | Title | Description |
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| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
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| Secondary | Anti-drug Antibody (ADA) Titers to ADCT-502 | | This analysis was planned but data was not collected as the study was terminated due to safety reasons. | Posted | | | | | | Blood sample collection before start of infusion in Cycles 1 and 2, and on Day 1 starting with Cycle 3 until disease progression, 30 days and 12 weeks after last dose | | | | ID | Title | Description |
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| OG000 | Part 1: Dose 30μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (30 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG001 | Part 1: Dose 60μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (60 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG002 | Part 1: Dose 120μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (120 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. | | OG003 | Part 1: Dose 150μg/kg | Dose-escalation part of the study. Participants received ADCT-502 (150 μg/kg) via a 1-hour intravenous infusion once every 3 weeks. |
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