TriangleNCT03215030 · OUTCOME
Part 1: 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 Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
What was measured
DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.
Analysis population: The DLT-evaluable Analysis Set included participants who received all Cycle 1 doses of modakafusp alfa or experienced a DLT in Cycle 1 in the Part 1 Dose Escalation portion of the study.
Groups in this outcome
Part 1 (Dose Escalation) Schedule A
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule C
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A | 13 |
| Part 1 (Dose Escalation) Schedule B | 6 |
| Part 1 (Dose Escalation) Schedule C | 7 |
| Part 1 (Dose Escalation) Schedule D | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.
- groups
- description
- Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 1 (Dose Escalation) Schedule A
- description
- Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 1 (Dose Escalation) Schedule B
- description
- Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 1 (Dose Escalation) Schedule C
- description
- Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 1 (Dose Escalation) Schedule D
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The DLT-evaluable Analysis Set included participants who received all Cycle 1 doses of modakafusp alfa or experienced a DLT in Cycle 1 in the Part 1 Dose Escalation portion of the study.
- reporting Status
- POSTED
- time Frame
- Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
- title
- Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice