TriangleNCT03621982 · OUTCOME
Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ratio
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
What was measured
The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. AI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
Analysis population: PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment. The overall number of participants analyzed represents the number of participants with available PK data at any timepoint. Includes participants with available data at each timepoint.
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 Combination 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 Combination 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 Combination 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 Combination 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 Combination 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 Combination 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 | 1 |
| ADCT-301 Monotherapy 30 µg/kg | 3 |
| ADCT-301 Monotherapy 45 µg/kg | 2 |
| ADCT-301 Monotherapy 60 µg/kg | 4 |
| ADCT-301 Monotherapy 80 µg/kg | 4 |
| ADCT-301 Monotherapy 100 µg/kg | 5 |
| ADCT-301 Monotherapy 125 µg/kg | 4 |
| ADCT-301 Monotherapy 150 µg/kg | 3 |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1 |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 5 |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 6 |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 3 |
Reported measurements
Conjugated Antibody Cycle 2
| Group | Source count |
|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 1 |
| ADCT-301 Monotherapy 30 µg/kg | 3 |
| ADCT-301 Monotherapy 45 µg/kg | 1 |
| ADCT-301 Monotherapy 60 µg/kg | 3 |
| ADCT-301 Monotherapy 80 µg/kg | 4 |
| ADCT-301 Monotherapy 100 µg/kg | 4 |
| ADCT-301 Monotherapy 125 µg/kg | 4 |
| ADCT-301 Monotherapy 150 µg/kg | 3 |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1 |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 4 |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 6 |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 1.00 | NA | Not reported | Not reported | Data not available due to insufficient number of observations to determine geometric coefficient of variation. |
| ADCT-301 Monotherapy 30 µg/kg | 1.00 | 0.175 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 1.00 | NA | Not reported | Not reported | Data not available due to insufficient number of observations to determine geometric coefficient of variation. |
| ADCT-301 Monotherapy 60 µg/kg | 1.09 | 7.42 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 1.01 | 0.621 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 1.02 | 2.41 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 1.04 | 4.67 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 1.03 | 2.39 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1.00 | NA | Not reported | Not reported | Data not available due to insufficient number of observations to determine geometric coefficient of variation. |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 1.00 | 0.123 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 1.01 | 1.05 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 1.00 | 0.570 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 1.00 | 0.258 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 1.02 | 1.28 | Not reported | Not reported | Not reported |
Total Antibody Cycle 2
| Group | Source count |
|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 1 |
| ADCT-301 Monotherapy 30 µg/kg | 3 |
| ADCT-301 Monotherapy 45 µg/kg | 2 |
| ADCT-301 Monotherapy 60 µg/kg | 4 |
| ADCT-301 Monotherapy 80 µg/kg | 4 |
| ADCT-301 Monotherapy 100 µg/kg | 5 |
| ADCT-301 Monotherapy 125 µg/kg | 4 |
| ADCT-301 Monotherapy 150 µg/kg | 2 |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1 |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 5 |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 5 |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 1.00 | NA | Not reported | Not reported | Data not available due to insufficient number of observations to determine geometric coefficient of variation. |
| ADCT-301 Monotherapy 30 µg/kg | 1.00 | 0.248 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 1.00 | 0.124 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 1.03 | 3.59 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 1.01 | 0.819 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 1.02 | 3.12 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 1.05 | 6.87 | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 1.05 | 4.03 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1.10 | NA | Not reported | Not reported | Data not available due to insufficient number of observations to determine geometric coefficient of variation. |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 1.00 | 0.257 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 1.03 | 3.73 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 1.00 | 0.305 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 1.01 | 0.757 | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 1.04 | 3.01 | Not reported | Not reported | Not reported |
Unconjugated SG3199 Cycle 2
| Group | Source count |
|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 |
| ADCT-301 Monotherapy 30 µg/kg | 0 |
| ADCT-301 Monotherapy 45 µg/kg | 0 |
| ADCT-301 Monotherapy 60 µg/kg | 0 |
| ADCT-301 Monotherapy 80 µg/kg | 0 |
| ADCT-301 Monotherapy 100 µg/kg | 0 |
| ADCT-301 Monotherapy 125 µg/kg | 0 |
| ADCT-301 Monotherapy 150 µg/kg | 0 |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 0 |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 0 |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 0 |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 0 |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 0 |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 0 |
Complete source fields
- classes
- categories
- measurements
- comment
- Data not available due to insufficient number of observations to determine geometric coefficient of variation.
- group Id
- OG000
- spread
- NA
- value
- 1.00
- group Id
- OG001
- spread
- 0.175
- value
- 1.00
- comment
- Data not available due to insufficient number of observations to determine geometric coefficient of variation.
- group Id
- OG002
- spread
- NA
- value
- 1.00
- group Id
- OG003
- spread
- 7.42
- value
- 1.09
- group Id
- OG004
- spread
- 0.621
- value
- 1.01
- group Id
- OG005
- spread
- 2.41
- value
- 1.02
- group Id
- OG006
- spread
- 4.67
- value
- 1.04
- group Id
- OG007
- spread
- 2.39
- value
- 1.03
- comment
- Data not available due to insufficient number of observations to determine geometric coefficient of variation.
- group Id
- OG008
- spread
- NA
- value
- 1.00
- group Id
- OG009
- spread
- 0.123
- value
- 1.00
- group Id
- OG010
- spread
- 1.05
- value
- 1.01
- group Id
- OG011
- spread
- 0.570
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Conjugated Antibody Cycle 2
- categories
- measurements
- comment
- Data not available due to insufficient number of observations to determine geometric coefficient of variation.
- group Id
- OG000
- spread
- NA
- value
- 1.00
- group Id
- OG001
- spread
- 0.248
- value
- 1.00
- group Id
- OG002
- spread
- 0.124
- value
- 1.00
- group Id
- OG003
- spread
- 3.59
- value
- 1.03
- group Id
- OG004
- spread
- 0.819
- value
- 1.01
- group Id
- OG005
- spread
- 3.12
- value
- 1.02
- group Id
- OG006
- spread
- 6.87
- value
- 1.05
- group Id
- OG007
- spread
- 4.03
- value
- 1.05
- comment
- Data not available due to insufficient number of observations to determine geometric coefficient of variation.
- group Id
- OG008
- spread
- NA
- value
- 1.10
- group Id
- OG009
- spread
- 0.257
- value
- 1.00
- group Id
- OG010
- spread
- 3.73
- value
- 1.03
- group Id
- OG011
- spread
- 0.305
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- Total Antibody Cycle 2
- denoms
- counts
- 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
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Unconjugated SG3199 Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues. AI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose. Upon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
- dispersion Type
- Geometric Coefficient of Variation
- 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 Combination 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 Combination 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 Combination 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 Combination Therapy 60 µg/kg + Pemb
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment. The overall number of participants analyzed represents the number of participants with available PK data at any timepoint. Includes participants with available data at each timepoint.
- reporting Status
- POSTED
- time Frame
- C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose
- title
- Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199
- type
- SECONDARY
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice