NCT03576131 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) 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 Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Analysis population: Pharmacokinetic (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
Cmax Hx-DR5-01 Cycle 1 (Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 6 |
|---|
| 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) | 0.86 | 36.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 1.90 | 38.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 2.81 | 28.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 9.79 | 20.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 21.31 | 24.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 29.75 | 24.9 | Not reported | Not reported | Not reported |
|---|
Cmax Hx-DR5-01 Cycle 2 (Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 4 |
|---|
| 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) | 0.79 | 42.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 2.11 | 18.3 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 1.12 | 59.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 8.36 | 22.7 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 13.13 | 156.3 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 29.56 | 7.7 | Not reported | Not reported | Not reported |
|---|
Cmax Hx-DR5-01 Cycle 3 (Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 4 |
|---|
| 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) | 0.89 | 16.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 1.82 | 53.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0.89 | 146.4 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 7.20 | 11.2 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 20.35 | 24.7 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 28.80 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
|---|
Cmax Hx-DR5-05 Cycle 1 (Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 6 |
|---|
| 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) | 0.87 | 45.2 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 1.81 | 35.7 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 2.82 | 31.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 9.72 | 17.0 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 20.90 | 21.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 29.44 | 27.9 | Not reported | Not reported | Not reported |
|---|
Cmax Hx-DR5-05 Cycle 2 (Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 9 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 8 |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 4 |
|---|
| 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) | 0.79 | 25.9 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 2.00 | 18.3 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 1.11 | 76.2 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 7.75 | 25.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 20.37 | 14.3 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 30.52 | 5.8 | Not reported | Not reported | Not reported |
|---|
Cmax Hx-DR5-05 Cycle 3 (Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 7 |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 4 |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 2 |
|---|
| 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) | 0.87 | 26.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 1.28 | 93.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 1.62 | 108.2 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 6.77 | 20.6 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 5.27 | 577.8 | Not reported | Not reported | Not reported |
|---|
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 28.50 | 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
- 36.8
- value
- 0.86
- group Id
- OG001
- spread
- 38.0
- value
- 1.90
- group Id
- OG002
- spread
- 28.9
- value
- 2.81
- group Id
- OG003
- spread
- 20.9
- value
- 9.79
- group Id
- OG004
- spread
- 24.6
- value
- 21.31
- group Id
- OG005
- spread
- 24.9
- value
- 29.75
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Cmax Hx-DR5-01 Cycle 1 (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 42.9
- value
- 0.79
- group Id
- OG001
- spread
- 18.3
- value
- 2.11
- group Id
- OG002
- spread
- 59.9
- value
- 1.12
- group Id
- OG003
- spread
- 22.7
- value
- 8.36
- group Id
- OG004
- spread
- 156.3
- value
- 13.13
- group Id
- OG005
- spread
- 7.7
- value
- 29.56
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Cmax Hx-DR5-01 Cycle 2 (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- 0.89
- group Id
- OG001
- spread
- 53.9
- value
- 1.82
- group Id
- OG002
- spread
- 146.4
- value
- 0.89
- group Id
- OG003
- spread
- 11.2
- value
- 7.20
- group Id
- OG004
- spread
- 24.7
- value
- 20.35
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG005
- spread
- NA
- value
- 28.80
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Cmax Hx-DR5-01 Cycle 3 (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 45.2
- value
- 0.87
- group Id
- OG001
- spread
- 35.7
- value
- 1.81
- group Id
- OG002
- spread
- 31.8
- value
- 2.82
- group Id
- OG003
- spread
- 17.0
- value
- 9.72
- group Id
- OG004
- spread
- 21.9
- value
- 20.90
- group Id
- OG005
- spread
- 27.9
- value
- 29.44
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Cmax Hx-DR5-05 Cycle 1 (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 25.9
- value
- 0.79
- group Id
- OG001
- spread
- 18.3
- value
- 2.00
- group Id
- OG002
- spread
- 76.2
- value
- 1.11
- group Id
- OG003
- spread
- 25.8
- value
- 7.75
- group Id
- OG004
- spread
- 14.3
- value
- 20.37
- group Id
- OG005
- spread
- 5.8
- value
- 30.52
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Cmax Hx-DR5-05 Cycle 2 (Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 26.6
- value
- 0.87
- group Id
- OG001
- spread
- 93.8
- value
- 1.28
- group Id
- OG002
- spread
- 108.2
- value
- 1.62
- group Id
- OG003
- spread
- 20.6
- value
- 6.77
- group Id
- OG004
- spread
- 577.8
- value
- 5.27
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG005
- spread
- NA
- value
- 28.50
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- units
- Participants
- title
- Cmax Hx-DR5-05 Cycle 3 (Day 1)
- 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 Cmax 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
- Pharmacokinetic (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
- Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
- type
- SECONDARY
- unit Of Measure
- µg/mL
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