TriangleNCT06048367 · OUTCOME
Evaluated as PD (Progressive Disease) in the Preliminary Efficacy Assessment.
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
- Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.
What was measured
Progressive Disease (PD): According to the modified RECIST v1.1 (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. The sum of the diameters of target lesions increases by at least 20% compared to the smallest sum recorded during the study (or baseline if it is the smallest).
Groups in this outcome
CNSI-Fe(II) 30 mg
30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
CNSI-Fe(II) 60 mg
60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
CNSI-Fe(II) 90 mg
90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
CNSI-Fe(II) 120 mg
120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
CNSI-Fe(II) 150 mg
150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
| Group | Source count |
|---|---|
| CNSI-Fe(II) 30 mg | 3 |
| CNSI-Fe(II) 60 mg | 4 |
| CNSI-Fe(II) 90 mg | 5 |
| CNSI-Fe(II) 120 mg | 3 |
| CNSI-Fe(II) 150 mg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CNSI-Fe(II) 30 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 60 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 90 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- units
- Participants
- description
- Progressive Disease (PD): According to the modified RECIST v1.1 (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. The sum of the diameters of target lesions increases by at least 20% compared to the smallest sum recorded during the study (or baseline if it is the smallest).
- groups
- description
- 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
- id
- OG000
- title
- CNSI-Fe(II) 30 mg
- description
- 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
- id
- OG001
- title
- CNSI-Fe(II) 60 mg
- description
- 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
- id
- OG002
- title
- CNSI-Fe(II) 90 mg
- description
- 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
- id
- OG003
- title
- CNSI-Fe(II) 120 mg
- description
- 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
- id
- OG004
- title
- CNSI-Fe(II) 150 mg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.
- title
- Evaluated as PD (Progressive Disease) in the Preliminary Efficacy Assessment.
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice