TriangleNCT03621982 · OUTCOME
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 to Day 21
What was measured
For the dose-escalation of ADCT-301 as monotherapy, DLT is defined as any of the following events like hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes. For the dose-escalation of ADCT-301 in combination with pembrolizumab, a DLT is defined as any of the following events ike hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.
Analysis population: DLT Analysis Set: The DLT-evaluable analysis set consisted of participants in Part 1 who received study drug.
Groups in this outcome
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Combined Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combined Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combined Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combined Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combined Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combined Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
| Group | Source count |
|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 3 |
| ADCT-301 Monotherapy 30 µg/kg | 5 |
| ADCT-301 Monotherapy 45 µg/kg | 5 |
| ADCT-301 Monotherapy 60 µg/kg | 5 |
| ADCT-301 Monotherapy 80 µg/kg | 8 |
| ADCT-301 Monotherapy 100 µg/kg | 7 |
| ADCT-301 Monotherapy 125 µg/kg | 8 |
| ADCT-301 Monotherapy 150 µg/kg | 3 |
| ADCT-301 Combined Therapy 20 µg/kg + Pemb | 1 |
| ADCT-301 Combined Therapy 30 µg/kg + Pemb | 4 |
| ADCT-301 Combined Therapy 45 µg/kg + Pemb | 10 |
| ADCT-301 Combined Therapy 60 µg/kg + Pemb | 9 |
| ADCT-301 Combined Therapy 80 µg/kg + Pemb | 4 |
| ADCT-301 Combined Therapy 100 µg/kg + Pemb | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combined Therapy 20 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combined Therapy 30 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combined Therapy 45 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combined Therapy 60 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combined Therapy 80 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combined Therapy 100 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 9
- units
- Participants
- description
- For the dose-escalation of ADCT-301 as monotherapy, DLT is defined as any of the following events like hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes. For the dose-escalation of ADCT-301 in combination with pembrolizumab, a DLT is defined as any of the following events ike hematologic DLT and non-hematologic DLT which occur during the 21 days following the first study drug administration period of Part 1, except those that are clearly due to underlying disease or extraneous causes.
- groups
- description
- Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- ADCT-301 Monotherapy 20 µg/kg
- description
- Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- ADCT-301 Monotherapy 30 µg/kg
- description
- Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- ADCT-301 Monotherapy 45 µg/kg
- description
- Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- ADCT-301 Monotherapy 60 µg/kg
- description
- Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- ADCT-301 Monotherapy 80 µg/kg
- description
- Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- ADCT-301 Monotherapy 100 µg/kg
- description
- Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG006
- title
- ADCT-301 Monotherapy 125 µg/kg
- description
- Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG007
- title
- ADCT-301 Monotherapy 150 µg/kg
- description
- Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG008
- title
- ADCT-301 Combined Therapy 20 µg/kg + Pemb
- description
- Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG009
- title
- ADCT-301 Combined Therapy 30 µg/kg + Pemb
- description
- Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG010
- title
- ADCT-301 Combined Therapy 45 µg/kg + Pemb
- description
- Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG011
- title
- ADCT-301 Combined Therapy 60 µg/kg + Pemb
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT Analysis Set: The DLT-evaluable analysis set consisted of participants in Part 1 who received study drug.
- reporting Status
- POSTED
- time Frame
- Day 1 to Day 21
- title
- Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice