TriangleNCT04442126 · OUTCOME
To Determine the Anti-tumor Activity (Best Overall Response) of NM21-1480 According to RECIST 1.1
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
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
What was measured
For best overall response (BOR) and objective response rate (ORR), patients in the Efficacy Analysis Set (EAS) who did not have sufficient on-study tumor assessments to characterize response were included in the denominator when calculating BOR percent and ORR and were thus treated as non-responders.
Analysis population: The ORR for each given group (dose level, cohort, or arm) in the EAS are summarized according to RECIST 1.1 (and according to iRECIST), accompanied by a 2-sided exact 95% Clopper-Pearson confidence interval (CI).
Groups in this outcome
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Part A Dose Level 3 NM21-1480-Q2W 8mg
Part A Dose Level 3 NM21-1480-Q2W 8mg
Part A Dose Level 4 NM21-1480-Q2W 24mg
Part A Dose Level 4 NM21-1480-Q2W 24mg
Part A Dose Level 5 NM21-1480-Q2W 80mg
Part A Dose Level 5 NM21-1480-Q2W 80mg
Part A Dose Level 6 NM21-1480-Q2W 240mg
Part A Dose Level 6 NM21-1480-Q2W 240mg
Part A Dose Level 7 NM21-1480-Q2W 800mg
Part A Dose Level 7 NM21-1480-Q2W 800mg
Part A2 NM21-1480-Q2W 1400mg
Part A2 NM21-1480-Q2W 1400mg
Part B NM21-1480-Q2W 800mg
Part B NM21-1480-Q2W 800mg
| Group | Source count |
|---|---|
| Part A Dose Level 1 NM21-1480-Q2W 0.15mg | 1 |
| Part A Dose Level 2 NM21-1480-Q2W 1.5mg | 1 |
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 3 |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 3 |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 6 |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 3 |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 9 |
| Part A2 NM21-1480-Q2W 1400mg | 5 |
| Part B NM21-1480-Q2W 800mg | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Level 1 NM21-1480-Q2W 0.15mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 2 NM21-1480-Q2W 1.5mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A2 NM21-1480-Q2W 1400mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B NM21-1480-Q2W 800mg | 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
- 1
- 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
- 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
- 6
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 21
- units
- Participants
- description
- For best overall response (BOR) and objective response rate (ORR), patients in the Efficacy Analysis Set (EAS) who did not have sufficient on-study tumor assessments to characterize response were included in the denominator when calculating BOR percent and ORR and were thus treated as non-responders.
- groups
- description
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- id
- OG000
- title
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- description
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- id
- OG001
- title
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- description
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- id
- OG002
- title
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- description
- Part A Dose Level 4 NM21-1480-Q2W 24mg
- id
- OG003
- title
- Part A Dose Level 4 NM21-1480-Q2W 24mg
- description
- Part A Dose Level 5 NM21-1480-Q2W 80mg
- id
- OG004
- title
- Part A Dose Level 5 NM21-1480-Q2W 80mg
- description
- Part A Dose Level 6 NM21-1480-Q2W 240mg
- id
- OG005
- title
- Part A Dose Level 6 NM21-1480-Q2W 240mg
- description
- Part A Dose Level 7 NM21-1480-Q2W 800mg
- id
- OG006
- title
- Part A Dose Level 7 NM21-1480-Q2W 800mg
- description
- Part A2 NM21-1480-Q2W 1400mg
- id
- OG007
- title
- Part A2 NM21-1480-Q2W 1400mg
- description
- Part B NM21-1480-Q2W 800mg
- id
- OG008
- title
- Part B NM21-1480-Q2W 800mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The ORR for each given group (dose level, cohort, or arm) in the EAS are summarized according to RECIST 1.1 (and according to iRECIST), accompanied by a 2-sided exact 95% Clopper-Pearson confidence interval (CI).
- reporting Status
- POSTED
- time Frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- title
- To Determine the Anti-tumor Activity (Best Overall Response) of NM21-1480 According to RECIST 1.1
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice