TriangleNCT04383210 · OUTCOME
Objective Response Rate
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 12 months
What was measured
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.
Analysis population: Among the 36 patients enrolled in Cohort 1, 29 of 36 patients met criteria (criteria includes centrally confirmed NRG1 fusion status and patient received 3,000 mg QW dosing) to be included in the primary efficacy population and were evaluable for investigator assessed response per RECIST v1.1. In Cohorts 2 and 3, one patient in each cohort was not evaluable for investigator assessed response per RECIST v1.1.
Groups in this outcome
Cohort 1
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
Cohort 2
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
Cohort 3
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
| Group | Source count |
|---|---|
| Cohort 1 | 29 |
| Cohort 2 | 10 |
| Cohort 3 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.
- groups
- description
- Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
- id
- OG000
- title
- Cohort 1
- description
- Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
- id
- OG001
- title
- Cohort 2
- description
- Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
- id
- OG002
- title
- Cohort 3
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Among the 36 patients enrolled in Cohort 1, 29 of 36 patients met criteria (criteria includes centrally confirmed NRG1 fusion status and patient received 3,000 mg QW dosing) to be included in the primary efficacy population and were evaluable for investigator assessed response per RECIST v1.1. In Cohorts 2 and 3, one patient in each cohort was not evaluable for investigator assessed response per RECIST v1.1.
- reporting Status
- POSTED
- time Frame
- Up to 12 months
- title
- Objective Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice