TriangleNCT05551117 · OUTCOME
Part 1: ORR Per PCWG3 Criteria as Determined by the Investigator
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
- Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months,
What was measured
To qualify as an objective response, CR and PR require confirmation at least 4 weeks after initial observation of complete response (CR) or partial response (PR). CR + PR = ORR
Analysis population: The analysis is limited to only participants with mCRPC who experienced a complete or partial response to study treatment. None of the participants in the control arm experienced a complete or partial response to study treatment. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
Groups in this outcome
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
| Group | Source count |
|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 59 |
| Part 1: MGC018 2.7 mg (Arm B) | 49 |
| Part 1: Control Arm | 3 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 13.6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: MGC018 2.7 mg (Arm B) | 30.6 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Control Arm | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13.6
- group Id
- OG001
- value
- 30.6
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- To qualify as an objective response, CR and PR require confirmation at least 4 weeks after initial observation of complete response (CR) or partial response (PR). CR + PR = ORR
- groups
- description
- vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
- id
- OG000
- title
- Part 1: MGC018 2.0 mg (Arm A)
- description
- vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
- id
- OG001
- title
- Part 1: MGC018 2.7 mg (Arm B)
- description
- abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
- id
- OG002
- title
- Part 1: Control Arm
- description
- vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
- id
- OG003
- title
- Part 2
- param Type
- NUMBER
- population Description
- The analysis is limited to only participants with mCRPC who experienced a complete or partial response to study treatment. None of the participants in the control arm experienced a complete or partial response to study treatment. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months,
- title
- Part 1: ORR Per PCWG3 Criteria as Determined by the Investigator
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice