Trial Outcomes & Findings for Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers (NCT NCT05483933)
NCT ID: NCT05483933
Last Updated: 2025-12-23
Results Overview
Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
86 participants
Primary outcome timeframe
From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Results posted on
2025-12-23
Participant Flow
Dose escalation was limited to a single dose level for SL-172154 within each arm (in combination with the standard dose of PLD or MIRV). No participants were enrolled in other dose levels in either arm.
Participant milestones
| Measure |
Pegylated Liposomal Doxorubicin + SL-172154
3.0 mg/kg SL-172154 on Days 8 and 15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
3.0 mg/kg SL-172154 on Days 8 and 15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
65
|
|
Overall Study
COMPLETED
|
21
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
Baseline characteristics by cohort
| Measure |
Pegylated Liposomal Doxorubicin + SL-172154
n=21 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=65 Participants
3.0 mg/kg SL-172154 on Days 8 and 15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=68 Participants
|
64 years
n=4 Participants
|
64 years
n=219 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=68 Participants
|
65 Participants
n=4 Participants
|
86 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=68 Participants
|
58 Participants
n=4 Participants
|
76 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=68 Participants
|
58 Participants
n=4 Participants
|
78 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=219 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=68 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=219 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=68 Participants
|
22 Participants
n=4 Participants
|
25 Participants
n=219 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=68 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=219 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=68 Participants
|
24 Participants
n=4 Participants
|
29 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 monthsPopulation: Subjects who received at least one dose of SL-172154, PLD or Mirvetixumab
Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=21 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=65 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab
|
20 Participants
|
65 Participants
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 monthsPopulation: DLT evaluable population (Dose Escalation only)
Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects"
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=8 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=7 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab
|
3.0 mg/kg
|
3.0 mg/kg
|
—
|
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: Response Evaluable Population
Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=20 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=39 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
n=26 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
Progressive Disease
|
6 Participants
|
5 Participants
|
9 Participants
|
|
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
Complete response
|
0 Participants
|
1 Participants
|
0 Participants
|
|
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
Partial response
|
4 Participants
|
12 Participants
|
4 Participants
|
|
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
Stable Disease
|
10 Participants
|
21 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: Immunogenicity population.
Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=20 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=60 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Immunogenicity to SL-172154
|
0 Participants
|
38 Participants
|
—
|
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: Immunogenicity population
Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=60 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Immunogenicity to MIRV
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D8, C1D15, C2D8Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis
The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=18 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=42 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of SL-172154
C1D8
|
6022.23 ng/mL
Geometric Coefficient of Variation 253.65
|
13248.42 ng/mL
Geometric Coefficient of Variation 96.70
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-172154
C1D15
|
13893.69 ng/mL
Geometric Coefficient of Variation 90.44
|
8075.79 ng/mL
Geometric Coefficient of Variation 97.53
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-172154
C2D8
|
7083.44 ng/mL
Geometric Coefficient of Variation 110.77
|
10375.13 ng/mL
Geometric Coefficient of Variation 117.92
|
—
|
SECONDARY outcome
Timeframe: C1D8, C1D15 and C2D8Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis
The AUC is the area under the serum concentration time curve of SL-172154 following single and multiple doses
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=18 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=42 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Area Under the Serum Concentration-time Curve (AUC) of SL-172154
C1D8
|
9798.72 h*ng/mL
Geometric Coefficient of Variation 239.36
|
27736.48 h*ng/mL
Geometric Coefficient of Variation 79.72
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC) of SL-172154
C1D15
|
20157.25 h*ng/mL
Geometric Coefficient of Variation 87.41
|
15324.37 h*ng/mL
Geometric Coefficient of Variation 82.77
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC) of SL-172154
C2D8
|
11619.44 h*ng/mL
Geometric Coefficient of Variation 132.43
|
21906.25 h*ng/mL
Geometric Coefficient of Variation 116.59
|
—
|
SECONDARY outcome
Timeframe: C1D8, C1D15 and C2D8Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=18 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=42 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
C1D8
|
2.07 hours
Interval 1.9 to 4.1
|
2.22 hours
Interval 1.9 to 5.9
|
—
|
|
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
C1D15
|
2.15 hours
Interval 1.8 to 4.1
|
2.03 hours
Interval 1.8 to 4.5
|
—
|
|
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
C2D8
|
2.05 hours
Interval 1.1 to 4.4
|
2.28 hours
Interval 1.3 to 5.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each cycle, pre-dose and end of infusion (EOI)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis
The Cmax is the maximum observed serum concentration of MIRV following single and multiple doses
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=65 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of MIRV
C1D1 EOI
|
137446.1 ng/mL
Geometric Coefficient of Variation 15.8
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C2D1 Predose
|
3752.7 ng/mL
Geometric Coefficient of Variation 54.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C2D1- EOI
|
121883.2 ng/mL
Geometric Coefficient of Variation 71.5
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C3D1-PREDOSE
|
4210.7 ng/mL
Geometric Coefficient of Variation 49.9
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C3D1-EOI
|
122156.1 ng/mL
Geometric Coefficient of Variation 61.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C4D1-PREDOSE
|
3792.1 ng/mL
Geometric Coefficient of Variation 74.4
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C4D1-EOI
|
125434.5 ng/mL
Geometric Coefficient of Variation 16.1
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C5D1-PREDOSE
|
4296.6 ng/mL
Geometric Coefficient of Variation 55.4
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C5D1-EOI
|
130739.7 ng/mL
Geometric Coefficient of Variation 14.3
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C6D1-PREDOSE
|
4454.2 ng/mL
Geometric Coefficient of Variation 58.8
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C6D1-EOI
|
117049.6 ng/mL
Geometric Coefficient of Variation 11.5
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C7D1-PREDOSE
|
3896.1 ng/mL
Geometric Coefficient of Variation 64.2
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C7D1-EOI
|
103871.8 ng/mL
Geometric Coefficient of Variation 16.0
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C8D1-PREDOSE
|
5020.3 ng/mL
Geometric Coefficient of Variation 40.6
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C8D1-EOI
|
108193.1 ng/mL
Geometric Coefficient of Variation 13.3
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C9D1-PREDOSE
|
4989.8 ng/mL
Geometric Coefficient of Variation 50.1
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C9D1-EOI
|
105523.9 ng/mL
Geometric Coefficient of Variation 16.4
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C10D1-PREDOSE
|
3372.2 ng/mL
Geometric Coefficient of Variation 116.3
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C10D1-EOI
|
105655.2 ng/mL
Geometric Coefficient of Variation 11.2
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C11D1-PREDOSE
|
5094.8 ng/mL
Geometric Coefficient of Variation 19.0
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of MIRV
C11D1-EOI
|
99787.8 ng/mL
Geometric Coefficient of Variation 11.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each cycle, pre-dose and end of infusion (EOI)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
The Cmax is the maximum observed serum concentration of Total Antibody (MIRV) following single and multiple doses
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=65 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C1D1-EOI
|
135716.4 ng/mL
Geometric Coefficient of Variation 16.0
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C2D1-PREDOSE
|
11901.6 ng/mL
Geometric Coefficient of Variation 65.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C2D1-EOI
|
135856.9 ng/mL
Geometric Coefficient of Variation 49.0
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C3D1-PREDOSE
|
15986.7 ng/mL
Geometric Coefficient of Variation 70.5
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C3D1-EOI
|
137898.7 ng/mL
Geometric Coefficient of Variation 37.9
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C4D1-PREDOSE
|
18388.2 ng/mL
Geometric Coefficient of Variation 61.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C4D1-EOI
|
136454.6 ng/mL
Geometric Coefficient of Variation 18.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C5D1-PREDOSE
|
20115.1 ng/mL
Geometric Coefficient of Variation 57.5
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C5D1-EOI
|
138756.5 ng/mL
Geometric Coefficient of Variation 22.2
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C6D1-PREDOSE
|
20283.3 ng/mL
Geometric Coefficient of Variation 63.6
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C6D1-EOI
|
123020.4 ng/mL
Geometric Coefficient of Variation 28.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C7D1-PREDOSE
|
19007.7 ng/mL
Geometric Coefficient of Variation 51.4
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C7D1-EOI
|
115087.0 ng/mL
Geometric Coefficient of Variation 29.0
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C8D1-PREDOSE
|
24546.8 ng/mL
Geometric Coefficient of Variation 52.2
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C8D1-EOI
|
121205.9 ng/mL
Geometric Coefficient of Variation 16.1
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C9D1-EOI
|
118301.1 ng/mL
Geometric Coefficient of Variation 12.6
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C10D1-PREDOSE
|
17972.6 ng/mL
Geometric Coefficient of Variation 144.5
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C10D1-EOI
|
110207.7 ng/mL
Geometric Coefficient of Variation 21.1
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C11D1-PREDOSE
|
29331.9 ng/mL
Geometric Coefficient of Variation 9.7
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C11D1-EOI
|
101638.6 ng/mL
Geometric Coefficient of Variation 57.1
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)
C9D1-PREDOSE
|
23604.6 ng/mL
Geometric Coefficient of Variation 69.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of each cycle, pre-dose and end of infusion (EOI)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
The Cmax is the maximum observed serum concentration of DM4 Payload and S-Methyl DM4 payload following single and multiple doses
Outcome measures
| Measure |
Pegylated Liposomal Doxorubicin (PLD) + SL-172154
n=65 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=65 Participants
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154
3.0 mg/kg SL-172154 on Days 8 and15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C1D1-EOI
|
4.539 ng/mL
Geometric Coefficient of Variation 40.775
|
0.191 ng/mL
Geometric Coefficient of Variation 52.463
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C2D1-PREDOSE
|
0.102 ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.798 ng/mL
Geometric Coefficient of Variation 108.344
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C2D1-EOI
|
4.353 ng/mL
Geometric Coefficient of Variation 48.036
|
3.228 ng/mL
Geometric Coefficient of Variation 86.763
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C3D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.711 ng/mL
Geometric Coefficient of Variation 98.646
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C3D1-EOI
|
4.242 ng/mL
Geometric Coefficient of Variation 45.189
|
2.712 ng/mL
Geometric Coefficient of Variation 82.341
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C4D1-PREDOSE
|
0.105 ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.645 ng/mL
Geometric Coefficient of Variation 81.145
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C4D1-EOI
|
4.190 ng/mL
Geometric Coefficient of Variation 39.346
|
2.336 ng/mL
Geometric Coefficient of Variation 61.288
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C5D1-PREDOSE
|
0.143 ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.513 ng/mL
Geometric Coefficient of Variation 57.029
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C5D1-EOI
|
3.495 ng/mL
Geometric Coefficient of Variation 49.810
|
1.812 ng/mL
Geometric Coefficient of Variation 73.839
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C6D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.565 ng/mL
Geometric Coefficient of Variation 34.199
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C6D1-EOI
|
3.370 ng/mL
Geometric Coefficient of Variation 38.460
|
1.963 ng/mL
Geometric Coefficient of Variation 53.070
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C7D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.500 ng/mL
Geometric Coefficient of Variation 67.093
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C7D1-EOI
|
3.486 ng/mL
Geometric Coefficient of Variation 55.862
|
1.460 ng/mL
Geometric Coefficient of Variation 117.897
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C8D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.736 ng/mL
Geometric Coefficient of Variation 53.285
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C8D1-EOI
|
2.591 ng/mL
Geometric Coefficient of Variation 29.962
|
2.238 ng/mL
Geometric Coefficient of Variation 64.838
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C9D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.526 ng/mL
Geometric Coefficient of Variation 24.536
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C9D1-EOI
|
1.847 ng/mL
Geometric Coefficient of Variation 30.813
|
1.438 ng/mL
Geometric Coefficient of Variation 50.514
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C11D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.728 ng/mL
Geometric Coefficient of Variation 77.130
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C11D1-EOI
|
2.245 ng/mL
Geometric Coefficient of Variation 9.463
|
1.544 ng/mL
Geometric Coefficient of Variation 23.568
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C10D1-PREDOSE
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.700 ng/mL
Geometric Coefficient of Variation 17.815
|
—
|
|
Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)
C10D1-EOI
|
2.583 ng/mL
Geometric Coefficient of Variation 74.475
|
1.599 ng/mL
Geometric Coefficient of Variation 56.348
|
—
|
Adverse Events
Pegylated Liposomal Doxorubicin + SL-172154
Serious events: 4 serious events
Other events: 20 other events
Deaths: 12 deaths
Mirvetuximab + SL-172154
Serious events: 17 serious events
Other events: 65 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Pegylated Liposomal Doxorubicin + SL-172154
n=21 participants at risk
3.0 mg/kg SL-172154 on Days 8 an15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=65 participants at risk
3.0 mg/kg SL-172154 on Days 8 and 15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Ileus
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Lower respiratory tract infection
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
General physical health deterioration
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
3.1%
2/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
3.1%
2/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Urosepsis
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Vascular disorders
Embolism
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
Other adverse events
| Measure |
Pegylated Liposomal Doxorubicin + SL-172154
n=21 participants at risk
3.0 mg/kg SL-172154 on Days 8 an15 of every 28-day cycle plus pegylated liposomal doxorubicin (PLD) 40 mg/m2 on Day 1 of every 28-day cycle
|
Mirvetuximab + SL-172154
n=65 participants at risk
3.0 mg/kg SL-172154 on Days 8 and 15 of every 21-day cycle plus mirvetuximab (MIRV) 6.0 mg/kg on Day 1 of every 21-day cycle
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
42.9%
9/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
27.7%
18/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
26.2%
17/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Diarrhoea
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
46.2%
30/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Stomatitis
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
vomiting
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
24.6%
16/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
4.6%
3/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Dysphagia
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Cataract
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Vitreous floaters
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Fatigue
|
42.9%
9/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
40.0%
26/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Nausea
|
52.4%
11/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
49.2%
32/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Vision Blurred
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
58.5%
38/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
30.8%
20/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Keratopathy
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
29.2%
19/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Keratitis
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
23.1%
15/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Photophobia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
13.8%
9/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Eye Pain
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Eye disorders
Visual impairment
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Mucosal inflammation
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Oedema peripheral
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
3.1%
2/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
12.3%
8/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Pyrexia
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
4.6%
3/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Asthenia
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
24.6%
16/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
General disorders
Chills
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
9/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
13.8%
9/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
23.1%
15/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
30.8%
20/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
3.1%
2/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Folliculitis
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Tooth infection
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
3.1%
2/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Vulvovaginal candidiasis
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Infections and infestations
COVID-19
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
5/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
1.5%
1/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
3.1%
2/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
18.5%
12/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
16.9%
11/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
10.8%
7/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
18.5%
12/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
20.0%
13/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
23.1%
15/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
40.0%
26/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
23.8%
5/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
58.5%
38/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
47.7%
31/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
46.2%
30/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Investigations
Blood alkaline phosphatase increased
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
7.7%
5/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Investigations
Weight decreased
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Vascular disorders
Embolism
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
0.00%
0/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
6.2%
4/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
9.2%
6/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
10.8%
7/65 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, through 30 days after the last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
Serious Treatment-Emergent Adverse Events by Preferred Term
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site agrees not to publish any Study Results or data before the publication of results from the Overall Study. After Sponsor has published the results of the Overall Study, Site may publish or present results generated at Site. If Sponsor has not published results of the Overall Study within 18 months of data base lock, Site may publish the results of the Study that were generated at Site. Site agrees to first submit to Sponsor the proposed publication at least 30 days prior to the submission.
- Publication restrictions are in place
Restriction type: OTHER