TriangleNCT04106492 · OUTCOME
Phase 2a: Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants with an objective response
- Interval / dispersion
- Not reported
- Time frame
- Up to 1 year
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Groups in this outcome
Cohort A (10 mL SQL70 and 185 mg/m2/Day of SQP33)
Participants will receive SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion as determined in Dose Escalation. Then will receive a lower dose than RP2D of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle. SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
Phase 2a Expansion Group 1 (Extremity STS) (10 mL SQL70 and 250 mg/m2/Day of SQP33)
Participants with soft tissue sarcomas of the extremity AJCC Stage III OR IV (\>5 cm injectable tumors locally advanced and or metastatic, not amendable to primary surgical intervention and who are anthracycline naïve. SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
| Group | Source count |
|---|---|
| Cohort A (10 mL SQL70 and 185 mg/m2/Day of SQP33) | 1 |
| Phase 2a Expansion Group 1 (Extremity STS) (10 mL SQL70 and 250 mg/m2/Day of SQP33) | 2 |
| P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) | 6 |
| P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (10 mL SQL70 and 185 mg/m2/Day of SQP33) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Expansion Group 1 (Extremity STS) (10 mL SQL70 and 250 mg/m2/Day of SQP33) | 1 | Not reported | Not reported | Not reported | Not reported |
| P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) | 0 | Not reported | Not reported | Not reported | Not reported |
| P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- groups
- description
- Participants will receive SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion as determined in Dose Escalation. Then will receive a lower dose than RP2D of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle. SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
- id
- OG000
- title
- Cohort A (10 mL SQL70 and 185 mg/m2/Day of SQP33)
- description
- Participants with soft tissue sarcomas of the extremity AJCC Stage III OR IV (\>5 cm injectable tumors locally advanced and or metastatic, not amendable to primary surgical intervention and who are anthracycline naïve. SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
- id
- OG001
- title
- Phase 2a Expansion Group 1 (Extremity STS) (10 mL SQL70 and 250 mg/m2/Day of SQP33)
- description
- 10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
- id
- OG002
- title
- P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
- description
- 10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
- id
- OG003
- title
- P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Phase 2a: Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- participants with an objective response
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice