TriangleNCT03576131 · OUTCOME
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (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 Day 1 through 8.8 months (corresponding to maximum observed duration)
What was measured
The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to \<10 mm of any pathological and non-pathological lymph nodes. The PR was defined as \>=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.
Analysis population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Groups in this outcome
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
| Group | Source count |
|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 10 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 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
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to \<10 mm of any pathological and non-pathological lymph nodes. The PR was defined as \>=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.
- groups
- description
- Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
- id
- OG000
- title
- Biweekly Regimen (GEN1029 0.1 mg/kg)
- description
- Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG001
- title
- Biweekly Regimen (GEN1029 0.2 mg/kg)
- description
- Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG002
- title
- Biweekly Regimen (GEN1029 0.3 mg/kg)
- description
- Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG003
- title
- Biweekly Regimen (GEN1029 1.0 mg/kg)
- description
- Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG004
- title
- Biweekly Regimen (GEN1029 2.0 mg/kg)
- description
- Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG005
- title
- Biweekly Regimen (GEN1029 3.0 mg/kg)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 8.8 months (corresponding to maximum observed duration)
- title
- Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice