TriangleNCT04824794 · OUTCOME
Dose Escalation and Expansion Part A: Number of Participants With Anti-Drug Antibodies (ADAs) to GEN3014
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Dose Escalation: Baseline up to a max of approx. 34.5 months, Expansion Part A: Baseline up to a max of approx. 16.6 months
What was measured
Venous blood samples were drawn for analysis of ADAs to GEN3014.
Analysis population: Immunogenicity Analysis Set=all enrolled participants who received at least 1 dose of trial drug, had a baseline and at least 1 evaluable on-treatment ADA sample.
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 | 10 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 4 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 4 |
| RRMM Expansion Part A: GEN3014 | 9 |
| R/R DLBCL Expansion Part A: GEN3014 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| RRMM Expansion Part A: GEN3014 | 1 | Not reported | Not reported | Not reported | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 1
- group Id
- OG008
- value
- 0
- 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
- 10
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 1
- units
- Participants
- description
- Venous blood samples were drawn for analysis of ADAs to GEN3014.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Immunogenicity Analysis Set=all enrolled participants who received at least 1 dose of trial drug, had a baseline and at least 1 evaluable on-treatment ADA sample.
- reporting Status
- POSTED
- time Frame
- Dose Escalation: Baseline up to a max of approx. 34.5 months, Expansion Part A: Baseline up to a max of approx. 16.6 months
- title
- Dose Escalation and Expansion Part A: Number of Participants With Anti-Drug Antibodies (ADAs) to GEN3014
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice