TriangleNCT04824794 · OUTCOME
Dose Escalation and Expansion Part A: Maximum (Peak) Plasma Concentration (Cmax) of GEN3014
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms per milliliter (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 (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, pharmacokinetic (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 who had 1+ PK sample collected with a valid bioanalytical result. Overall number of participants analyzed = number of participants evaluable for the outcome measure. Number analyzed=participants evaluable at the 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 | 11 |
| 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 | 11 |
| R/R DLBCL Expansion Part A: GEN3014 | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 2.820 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 22.900 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 67.302 | 45.089 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 129.119 | 16.987 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 258.004 | 16.432 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 345.758 | 21.679 | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 49.653 | 55.935 | Not reported | Not reported | Not reported |
| RRMM Expansion Part A: GEN3014 | 227.856 | 54.030 | Not reported | Not reported | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 218.849 | 51.836 | 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 | 10.600 | 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 | 8 |
| R/R DLBCL Expansion Part A: GEN3014 | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 14.000 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 45.600 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 85.393 | 33.351 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 230.426 | 10.913 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 395.829 | 29.396 | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 522.724 | 7.718 | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 123.418 | 13.794 | Not reported | Not reported | Not reported |
| RRMM Expansion Part A: GEN3014 | 384.109 | 20.034 | Not reported | Not reported | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 373.000 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.820
- group Id
- OG001
- value
- 22.900
- group Id
- OG002
- spread
- 45.089
- value
- 67.302
- group Id
- OG003
- spread
- 16.987
- value
- 129.119
- group Id
- OG004
- spread
- 16.432
- value
- 258.004
- group Id
- OG005
- spread
- 21.679
- value
- 345.758
- group Id
- OG006
- spread
- 55.935
- value
- 49.653
- group Id
- OG007
- spread
- 54.030
- value
- 227.856
- group Id
- OG008
- spread
- 51.836
- value
- 218.849
- 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
- 11
- group Id
- OG008
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 10.600
- 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
- 14.000
- group Id
- OG001
- value
- 45.600
- group Id
- OG002
- spread
- 33.351
- value
- 85.393
- group Id
- OG003
- spread
- 10.913
- value
- 230.426
- group Id
- OG004
- spread
- 29.396
- value
- 395.829
- group Id
- OG005
- spread
- 7.718
- value
- 522.724
- group Id
- OG006
- spread
- 13.794
- value
- 123.418
- group Id
- OG007
- spread
- 20.034
- value
- 384.109
- group Id
- OG008
- value
- 373.000
- 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
- 8
- group Id
- OG008
- value
- 1
- 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
- 11
- 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, pharmacokinetic (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 who had 1+ PK sample collected with a valid bioanalytical result. Overall number of participants analyzed = number of participants evaluable for the outcome measure. Number analyzed=participants evaluable at the 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 (cycle =28 days)
- title
- Dose Escalation and Expansion Part A: Maximum (Peak) Plasma Concentration (Cmax) of GEN3014
- type
- SECONDARY
- unit Of Measure
- micrograms per milliliter (ug/mL)
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Preserved source evidence · Not medical advice