NCT06160609 · OUTCOME
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin
Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM · Source last updated 2024-03-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ng/mL
- Interval / dispersion
- Full Range
- Time frame
- Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
What was measured
Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin.
Analysis population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.
Groups in this outcome
1.9 mg/kg Belantamab Mafodotin + 8mg OX40
Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
2.5 mg/kg Belantamab Mafodotin + 8mg OX40
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Reported measurements
Cycle 1 Day 1, Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | 0 | 0 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | 0 | 0 | Not reported |
|---|
Cycle 1 Day 1, End Of Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 1199.5 | Not reported | 0 | 1478 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 1759.0 | Not reported | 1746 | 2671 | Not reported |
|---|
Cycle 1 Day 1, 24 hours
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 1078.0 | Not reported | 712 | 1305 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 1540.0 | Not reported | 1427 | 1974 | Not reported |
|---|
Cycle 1 Day 1, 2-4 hours
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 1576.0 | Not reported | 1137 | 1659 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 1888.0 | Not reported | 1785 | 1889 | Not reported |
|---|
Cycle 1 Day 4
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 6 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 576.5 | Not reported | 428 | 770 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 889.0 | Not reported | 751 | 1087 | Not reported |
|---|
Cycle 1 Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 5 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 358.0 | Not reported | 0 | 545 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 737.0 | Not reported | 487 | 874 | Not reported |
|---|
Cycle 1 Day 22
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 1 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 1 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 326.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1, Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 5 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | 0 | 0 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | 0 | 0 | Not reported |
|---|
Cycle 4 Day 1, Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 3 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 1 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | 0 | 551 | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 6 Day 1, Pre-Dose
Analysis denominator · Participants
| Group | Source count |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 1 |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 1 |
|---|
Values in ng/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2.5 mg/kg Belantamab Mafodotin + 8mg OX40 | 346.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1, Pre-Dose
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 1478
- value
- 1199.5
- group Id
- OG001
- lower Limit
- 1746
- upper Limit
- 2671
- value
- 1759.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1, End Of Infusion
- categories
- measurements
- group Id
- OG000
- lower Limit
- 712
- upper Limit
- 1305
- value
- 1078.0
- group Id
- OG001
- lower Limit
- 1427
- upper Limit
- 1974
- value
- 1540.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1, 24 hours
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1137
- upper Limit
- 1659
- value
- 1576.0
- group Id
- OG001
- lower Limit
- 1785
- upper Limit
- 1889
- value
- 1888.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1, 2-4 hours
- categories
- measurements
- group Id
- OG000
- lower Limit
- 428
- upper Limit
- 770
- value
- 576.5
- group Id
- OG001
- lower Limit
- 751
- upper Limit
- 1087
- value
- 889.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 545
- value
- 358.0
- group Id
- OG001
- lower Limit
- 487
- upper Limit
- 874
- value
- 737.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 326.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 22
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 2 Day 1, Pre-Dose
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 551
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 4 Day 1, Pre-Dose
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 346.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 6 Day 1, Pre-Dose
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin.
- dispersion Type
- Full Range
- groups
- description
- Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
- id
- OG000
- title
- 1.9 mg/kg Belantamab Mafodotin + 8mg OX40
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
- id
- OG001
- title
- 2.5 mg/kg Belantamab Mafodotin + 8mg OX40
- param Type
- MEDIAN
- population Description
- Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.
- reporting Status
- POSTED
- time Frame
- Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
- title
- DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin
- type
- SECONDARY
- unit Of Measure
- ng/mL
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