TriangleNCT03215030 · OUTCOME
Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
What was measured
ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. Percentages were rounded off to the nearest decimal.
Analysis population: The Immunogenicity-evaluable Analysis Set included participants from the SAS with a baseline assessment and at least 1 postbaseline immunogenicity assessment. Overall number of participants analyzed is the number of participants with data available for analyses.
Groups in this outcome
Part 1 (Dose Escalation) Schedule A
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule C
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A | 17 |
| Part 1 (Dose Escalation) Schedule B | 6 |
| Part 1 (Dose Escalation) Schedule C | 6 |
| Part 1 (Dose Escalation) Schedule D | 18 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 7 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 3 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 21 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 7 |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 65 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A | 41.2 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 57.1 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 61.9 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 14.3 | Not reported | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 52.3 | Not reported | Not reported | Not reported | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 61.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41.2
- group Id
- OG001
- value
- 83.3
- group Id
- OG002
- value
- 83.3
- group Id
- OG003
- value
- 66.7
- group Id
- OG004
- value
- 57.1
- group Id
- OG005
- value
- 66.7
- group Id
- OG006
- value
- 61.9
- group Id
- OG007
- value
- 14.3
- group Id
- OG008
- value
- 52.3
- group Id
- OG009
- value
- 61.5
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 21
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 65
- group Id
- OG009
- value
- 65
- units
- Participants
- description
- ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. Percentages were rounded off to the nearest decimal.
- groups
- description
- Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 1 (Dose Escalation) Schedule A
- description
- Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 1 (Dose Escalation) Schedule B
- description
- Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 1 (Dose Escalation) Schedule C
- description
- Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 1 (Dose Escalation) Schedule D
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG004
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG005
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG006
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG007
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG008
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG009
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- param Type
- NUMBER
- population Description
- The Immunogenicity-evaluable Analysis Set included participants from the SAS with a baseline assessment and at least 1 postbaseline immunogenicity assessment. Overall number of participants analyzed is the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
- title
- Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice