TriangleNCT01609556 · OUTCOME
Number of Participants With Anti-Drug Antibodies (ADA)
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 follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
What was measured
During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.
Analysis population: Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.
Groups in this outcome
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
| Group | Source count |
|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 2 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 1 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 1 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 1 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 9 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 18 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 7 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 5 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 5 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 4 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 9 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 7 |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 46 |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 24 |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 27 |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 7
- units
- Participants
- description
- During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.
- groups
- description
- Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG000
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG001
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG002
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG003
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG004
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG005
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG006
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG007
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG008
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
- description
- Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG009
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
- description
- Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG010
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
- description
- Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG011
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.
- reporting Status
- POSTED
- time Frame
- Baseline up to follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
- title
- Number of Participants With Anti-Drug Antibodies (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice