TriangleNCT04434469 · OUTCOME
Objective Response Rate (ORR)
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
- Baseline up to approximately 19 months
What was measured
ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
Groups in this outcome
Dose Escalation Cohort 1: RO7297089
Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Cohort 2: RO7297089
Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Cohort 3: RO7297089
Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Cohort 4: RO7297089
Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Dose Escalation Backfill Cohort 4: RO7297089
Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
Dose Escalation Cohort 5: RO7297089
Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: RO7297089 | 3 |
| Dose Escalation Cohort 2: RO7297089 | 4 |
| Dose Escalation Cohort 3: RO7297089 | 4 |
| Dose Escalation Cohort 4: RO7297089 | 6 |
| Dose Escalation Backfill Cohort 4: RO7297089 | 5 |
| Dose Escalation Cohort 5: RO7297089 | 3 |
Reported measurements
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Backfill Cohort 4: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 1 | Not reported | Not reported | Not reported | Not reported |
Minimal Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Backfill Cohort 4: RO7297089 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Backfill Cohort 4: RO7297089 | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 2 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: RO7297089 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: RO7297089 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: RO7297089 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Backfill Cohort 4: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: RO7297089 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- 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
- 1
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Minimal Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Progressive disease
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
- groups
- description
- Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG000
- title
- Dose Escalation Cohort 1: RO7297089
- description
- Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG001
- title
- Dose Escalation Cohort 2: RO7297089
- description
- Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG002
- title
- Dose Escalation Cohort 3: RO7297089
- description
- Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
- id
- OG003
- title
- Dose Escalation Cohort 4: RO7297089
- description
- Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
- id
- OG004
- title
- Dose Escalation Backfill Cohort 4: RO7297089
- description
- Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
- id
- OG005
- title
- Dose Escalation Cohort 5: RO7297089
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Baseline up to approximately 19 months
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice