TriangleNCT02669017 · OUTCOME
Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
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
- Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
What was measured
Blood serum samples were collected and analysed to determine the presence or absence of ADA. ADA is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Analysis population: All participants who were tested for ADA.
Groups in this outcome
Parts 1 and 2: ADCT-402
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed: * Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W) * Dose Level 2: 30 μg/kg Day 1 Q3W * Dose Level 3: 60 μg/kg Day 1 Q3W * Dose Level 4: 90 μg/kg Day 1 Q3W * Dose Level 5: 120 μg/kg Day 1 Q3W * Dose Level 6: 150 μg/kg Day 1 Q3W * Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W). In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
| Group | Source count |
|---|---|
| Parts 1 and 2: ADCT-402 | 183 |
Reported measurements
Confirmed positive ADA pre-dose
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parts 1 and 2: ADCT-402 | 5 | Not reported | Not reported | Not reported | Not reported |
Confirmed positive ADA post-dose only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parts 1 and 2: ADCT-402 | 1 | Not reported | Not reported | Not reported | Not reported |
Confirmed positive ADA at anytime
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parts 1 and 2: ADCT-402 | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Confirmed positive ADA pre-dose
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Confirmed positive ADA post-dose only
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Confirmed positive ADA at anytime
- denoms
- counts
- group Id
- OG000
- value
- 183
- units
- Participants
- description
- Blood serum samples were collected and analysed to determine the presence or absence of ADA. ADA is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
- groups
- description
- In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed: * Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W) * Dose Level 2: 30 μg/kg Day 1 Q3W * Dose Level 3: 60 μg/kg Day 1 Q3W * Dose Level 4: 90 μg/kg Day 1 Q3W * Dose Level 5: 120 μg/kg Day 1 Q3W * Dose Level 6: 150 μg/kg Day 1 Q3W * Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W). In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
- id
- OG000
- title
- Parts 1 and 2: ADCT-402
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who were tested for ADA.
- reporting Status
- POSTED
- time Frame
- Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
- title
- Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice