TriangleNCT03386513 · OUTCOME
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
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
- Up to approximately 81 months
What was measured
DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Analysis population: The safety population included all participants who received at least 1 dose of study drug.
Groups in this outcome
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
| Group | Source count |
|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 3 |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 12 |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 13 |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 7 |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 5 |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 2 |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 3 |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 6 |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 1 | 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
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 14
- units
- Participants
- description
- DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG006
- title
- Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG007
- title
- Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG008
- title
- Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice