TriangleNCT04824794 · OUTCOME
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 Hours (AUC0-168 h) of GEN3014
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- day*ug/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (R/R DLBCL Expansion Part A: Cycle 1 Day 1 only) (cycle =28 days)
What was measured
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Analysis population: PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed=participants evaluable for the outcome measure. Number analyzed= participants evaluable at specified timepoint.
Groups in this outcome
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
| Group | Source count |
|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 9 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 5 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 4 |
| RRMM Expansion Part A: GEN3014 | 10 |
| R/R DLBCL Expansion Part A: GEN3014 | 2 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 9 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 5 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 4 |
| RRMM Expansion Part A: GEN3014 | 10 |
| R/R DLBCL Expansion Part A: GEN3014 | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 4.08 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 42.60 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 140.95 | 56.61 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 385.96 | 19.63 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 794.34 | 29.14 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 851.53 | 32.77 | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 139.66 | 57.75 | Not reported | Not reported | Not reported |
| RRMM Expansion Part A: GEN3014 | 585.08 | 35.23 | Not reported | Not reported | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 701.70 | 34.94 | Not reported | Not reported | Not reported |
Cycle 1 Day 8
| Group | Source count |
|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 0 |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 0 |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 0 |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 0 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 0 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 0 |
| RRMM Expansion Part A: GEN3014 | 0 |
| R/R DLBCL Expansion Part A: GEN3014 | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 19.70 | Not reported | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 9 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 2 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 2 |
| RRMM Expansion Part A: GEN3014 | 1 |
| R/R DLBCL Expansion Part A: GEN3014 | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 29.30 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 83.70 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 220.79 | 66.41 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 668.65 | 21.87 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 1086.85 | 45.83 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 1044.14 | 55.93 | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 275.42 | 3.34 | Not reported | Not reported | Not reported |
| RRMM Expansion Part A: GEN3014 | 828.00 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4.08
- group Id
- OG001
- value
- 42.60
- group Id
- OG002
- spread
- 56.61
- value
- 140.95
- group Id
- OG003
- spread
- 19.63
- value
- 385.96
- group Id
- OG004
- spread
- 29.14
- value
- 794.34
- group Id
- OG005
- spread
- 32.77
- value
- 851.53
- group Id
- OG006
- spread
- 57.75
- value
- 139.66
- group Id
- OG007
- spread
- 35.23
- value
- 585.08
- group Id
- OG008
- spread
- 34.94
- value
- 701.70
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 19.70
- denoms
- counts
- group Id
- OG000
- value
- 1
- 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
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- value
- 29.30
- group Id
- OG001
- value
- 83.70
- group Id
- OG002
- spread
- 66.41
- value
- 220.79
- group Id
- OG003
- spread
- 21.87
- value
- 668.65
- group Id
- OG004
- spread
- 45.83
- value
- 1086.85
- group Id
- OG005
- spread
- 55.93
- value
- 1044.14
- group Id
- OG006
- spread
- 3.34
- value
- 275.42
- group Id
- OG007
- value
- 828.00
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 2
- units
- Participants
- description
- Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
- id
- OG000
- title
- RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG001
- title
- RRMM Dose Escalation: GEN3014 2 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG002
- title
- RRMM Dose Escalation: GEN3014 4 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG003
- title
- RRMM Dose Escalation: GEN3014 8 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG004
- title
- RRMM Dose Escalation: GEN3014 16 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG005
- title
- RRMM Dose Escalation: GEN3014 24 mg/kg
- description
- Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
- id
- OG006
- title
- R/R AML Dose Escalation: GEN3014 Dose Level 1
- description
- Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
- id
- OG007
- title
- RRMM Expansion Part A: GEN3014
- description
- Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
- id
- OG008
- title
- R/R DLBCL Expansion Part A: GEN3014
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed=participants evaluable for the outcome measure. Number analyzed= participants evaluable at specified timepoint.
- reporting Status
- POSTED
- time Frame
- Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (R/R DLBCL Expansion Part A: Cycle 1 Day 1 only) (cycle =28 days)
- title
- Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 Hours (AUC0-168 h) of GEN3014
- type
- SECONDARY
- unit Of Measure
- day*ug/mL
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Preserved source evidence · Not medical advice