NCT03576131 · OUTCOME
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors · Source last updated 2023-08-01
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- µg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
What was measured
The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
Analysis population: PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Groups in this outcome
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 6 |
|---|
Reported measurements
Plasma concentration Hx-DR5-01 Cycle 1 Day 1 (predose)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 6 |
|---|
Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0.085 | 38.5 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
Plasma concentration Hx-DR5-01 Cycle 2 Day 1 (predose)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 8 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 8 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 5 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 2 |
|---|
Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0.091 | 61.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0.084 | 34.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0.230 | 77.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0.283 | 576.2 | Not reported | Not reported | Not reported |
|---|
Plasma concentration Hx-DR5-01 Cycle 3 Day 1 (predose)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 5 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 3 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 6 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 3 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 1 |
|---|
Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0.125 | 164.3 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0.090 | 46.4 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0.224 | 156.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0.739 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
|---|
Plasma concentration Hx-DR5-05 Cycle 1 Day 1 (predose)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 6 |
|---|
Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0.094 | 77.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
Plasma concentration Hx-DR5-05 Cycle 2 Day 1 (predose)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 8 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 8 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 5 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 2 |
|---|
Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0.097 | 83.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0.155 | 161.5 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0.240 | 372.5 | Not reported | Not reported | Not reported |
|---|
Plasma concentration Hx-DR5-05 Cycle 3 Day 1 (predose)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 5 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 3 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 6 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 3 |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 1 |
|---|
Values in µg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0.101 | 94.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0.119 | 138.5 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0.094 | 58.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0.075 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 0.568 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 38.5
- value
- 0.085
- group Id
- OG001
- spread
- 0.0
- value
- 0.075
- group Id
- OG002
- spread
- 0.0
- value
- 0.075
- group Id
- OG003
- spread
- 0.0
- value
- 0.075
- group Id
- OG004
- spread
- 0.0
- value
- 0.075
- group Id
- OG005
- spread
- 0.0
- value
- 0.075
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Plasma concentration Hx-DR5-01 Cycle 1 Day 1 (predose)
- categories
- measurements
- group Id
- OG000
- spread
- 61.0
- value
- 0.091
- group Id
- OG001
- spread
- 0.0
- value
- 0.075
- group Id
- OG002
- spread
- 0.0
- value
- 0.075
- group Id
- OG003
- spread
- 34.0
- value
- 0.084
- group Id
- OG004
- spread
- 77.8
- value
- 0.230
- group Id
- OG005
- spread
- 576.2
- value
- 0.283
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Plasma concentration Hx-DR5-01 Cycle 2 Day 1 (predose)
- categories
- measurements
- group Id
- OG000
- spread
- 0.0
- value
- 0.075
- group Id
- OG001
- spread
- 164.3
- value
- 0.125
- group Id
- OG002
- spread
- 0.0
- value
- 0.075
- group Id
- OG003
- spread
- 46.4
- value
- 0.090
- group Id
- OG004
- spread
- 156.9
- value
- 0.224
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG005
- spread
- NA
- value
- 0.739
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Plasma concentration Hx-DR5-01 Cycle 3 Day 1 (predose)
- categories
- measurements
- group Id
- OG000
- spread
- 77.6
- value
- 0.094
- group Id
- OG001
- spread
- 0.0
- value
- 0.075
- group Id
- OG002
- spread
- 0.0
- value
- 0.075
- group Id
- OG003
- spread
- 0.0
- value
- 0.075
- group Id
- OG004
- spread
- 0.0
- value
- 0.075
- group Id
- OG005
- spread
- 0.0
- value
- 0.075
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Plasma concentration Hx-DR5-05 Cycle 1 Day 1 (predose)
- categories
- measurements
- group Id
- OG000
- spread
- 83.6
- value
- 0.097
- group Id
- OG001
- spread
- 0.0
- value
- 0.075
- group Id
- OG002
- spread
- 0.0
- value
- 0.075
- group Id
- OG003
- spread
- 0.0
- value
- 0.075
- group Id
- OG004
- spread
- 161.5
- value
- 0.155
- group Id
- OG005
- spread
- 372.5
- value
- 0.240
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Plasma concentration Hx-DR5-05 Cycle 2 Day 1 (predose)
- categories
- measurements
- group Id
- OG000
- spread
- 94.6
- value
- 0.101
- group Id
- OG001
- spread
- 138.5
- value
- 0.119
- group Id
- OG002
- spread
- 0.0
- value
- 0.075
- group Id
- OG003
- spread
- 58.8
- value
- 0.094
- group Id
- OG004
- spread
- 0.0
- value
- 0.075
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG005
- spread
- NA
- value
- 0.568
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Plasma concentration Hx-DR5-05 Cycle 3 Day 1 (predose)
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
- id
- OG000
- title
- Biweekly Regimen (GEN1029 0.1 mg/kg)
- description
- Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG001
- title
- Biweekly Regimen (GEN1029 0.2 mg/kg)
- description
- Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG002
- title
- Biweekly Regimen (GEN1029 0.3 mg/kg)
- description
- Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG003
- title
- Biweekly Regimen (GEN1029 1.0 mg/kg)
- description
- Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG004
- title
- Biweekly Regimen (GEN1029 2.0 mg/kg)
- description
- Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG005
- title
- Biweekly Regimen (GEN1029 3.0 mg/kg)
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
- reporting Status
- POSTED
- time Frame
- Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
- title
- Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
- type
- SECONDARY
- unit Of Measure
- µg/mL
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