TriangleNCT02988817 · OUTCOME
Cmax of MMAE for Dose-escalation Part
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- pg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
What was measured
The Cmax of MMAE for dose-escalation part is reported.
Analysis population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Groups in this outcome
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 11 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 6 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 6 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 700.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 947.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 1874.13 | 5 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 4036.47 | 81.8 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 4265.60 | 46.1 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 5154.58 | 61.9 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 5617.89 | 34.7 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 161.140 | 75.0 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 175.315 | 159.4 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 303.977 | 45.3 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 244.623 | 48.9 | Not reported | Not reported | Not reported |
Cycle 1 Day 8
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 6 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 738.227 | 28.2 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 766.467 | 91.4 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 1982.67 | 58.1 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 1553.93 | 86.2 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 6 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 1715.54 | 42.8 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 2525.75 | 54.7 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 4379.50 | 58.2 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3720.00 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
Cycle 3 Day 1
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 8 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 4 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 631.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1200.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 628.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 6500.00 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 3964.40 | 49.4 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 4127.31 | 39.3 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 2180.00 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 442.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 558.000 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
Cycle 3 Day 8
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 1060.00 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
Cycle 3 Day 15
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 0 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 2960.00 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 5190.00 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG000
- spread
- NA
- value
- 700.000
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG001
- spread
- NA
- value
- 947.000
- group Id
- OG002
- spread
- 5
- value
- 1874.13
- group Id
- OG003
- spread
- 81.8
- value
- 4036.47
- group Id
- OG004
- spread
- 46.1
- value
- 4265.60
- group Id
- OG005
- spread
- 61.9
- value
- 5154.58
- group Id
- OG006
- spread
- 34.7
- value
- 5617.89
- group Id
- OG007
- spread
- 75.0
- value
- 161.140
- group Id
- OG008
- spread
- 159.4
- value
- 175.315
- group Id
- OG009
- spread
- 45.3
- value
- 303.977
- group Id
- OG010
- spread
- 48.9
- value
- 244.623
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG007
- spread
- 28.2
- value
- 738.227
- group Id
- OG008
- spread
- 91.4
- value
- 766.467
- group Id
- OG009
- spread
- 58.1
- value
- 1982.67
- group Id
- OG010
- spread
- 86.2
- value
- 1553.93
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG007
- spread
- 42.8
- value
- 1715.54
- group Id
- OG008
- spread
- 54.7
- value
- 2525.75
- group Id
- OG009
- spread
- 58.2
- value
- 4379.50
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG010
- spread
- NA
- value
- 3720.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG000
- spread
- NA
- value
- 631.000
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG001
- spread
- NA
- value
- 1200.000
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG002
- spread
- NA
- value
- 628.000
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG003
- spread
- NA
- value
- 6500.00
- group Id
- OG004
- spread
- 49.4
- value
- 3964.40
- group Id
- OG005
- spread
- 39.3
- value
- 4127.31
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG006
- spread
- NA
- value
- 2180.00
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG008
- spread
- NA
- value
- 442.000
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG009
- spread
- NA
- value
- 558.000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG008
- spread
- NA
- value
- 1060.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- units
- Participants
- title
- Cycle 3 Day 8
- categories
- measurements
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG008
- spread
- NA
- value
- 2960.00
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG009
- spread
- NA
- value
- 5190.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- units
- Participants
- title
- Cycle 3 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- units
- Participants
- description
- The Cmax of MMAE for dose-escalation part is reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
- id
- OG000
- title
- Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
- id
- OG001
- title
- Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
- id
- OG002
- title
- Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
- id
- OG003
- title
- Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
- id
- OG004
- title
- Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG005
- title
- Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
- id
- OG006
- title
- Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
- id
- OG007
- title
- Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
- id
- OG008
- title
- Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
- id
- OG009
- title
- Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
- id
- OG010
- title
- Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
- reporting Status
- POSTED
- time Frame
- For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
- title
- Cmax of MMAE for Dose-escalation Part
- type
- SECONDARY
- unit Of Measure
- pg/mL
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Preserved source evidence · Not medical advice