TriangleNCT02663518 · OUTCOME
Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
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
- Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
What was measured
A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> 4-fold dilution increase in titer from baseline in \> 1 post-treatment sample (treatment-boosted).
Analysis population: Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.
Groups in this outcome
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
| Group | Source count |
|---|---|
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 94 |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 11 |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 36 |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 37 |
Reported measurements
ADA Positive: Overall Incidence
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 14 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 5 | Not reported | Not reported | Not reported | Not reported |
NAb Positive: Overall Incidence
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- title
- ADA Positive: Overall Incidence
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- NAb Positive: Overall Incidence
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 37
- units
- Participants
- description
- A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> 4-fold dilution increase in titer from baseline in \> 1 post-treatment sample (treatment-boosted).
- groups
- description
- Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
- description
- Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
- id
- OG001
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
- description
- Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
- id
- OG002
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
- description
- Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.
- reporting Status
- POSTED
- time Frame
- Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
- title
- Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice