NCT03894618 · OUTCOME

Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)

SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas · Source last updated 2025-04-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: hours
Interval / dispersion: Full Range
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)

What was measured

The Tmax is the time at which the maximum concentration of SL-279252 is observed following single and multiple doses

Analysis 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.

Groups in this outcome

SL-279252 (0.0001 mg/kg S1)

0.0001 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (0.001 mg/kg S1)

0.001 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (0.003 mg/kg S1)

0.003 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (0.01 mg/kg S1)

0.01 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (0.03 mg/kg S1)

0.03 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (0.1 mg/kg S1)

0.1 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (0.3 mg/kg S1 or S2)

0.3 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)

SL-279252 (1.0 mg/kg S1 or S2)

1.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)

SL-279252 (3.0 mg/kg S1 or S2)

3.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)

SL-279252 (6.0 mg/kg S1)

6.0 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (12.0 mg/kg S1)

12.0 mg/kg of IV SL-279252 (Schedule 1)

SL-279252 (24.0 mg/kg S1)

24.0 mg/kg of IV SL-279252 (Schedule 1)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
SL-279252 (0.0001 mg/kg S1)	1
SL-279252 (0.001 mg/kg S1)	1
SL-279252 (0.003 mg/kg S1)	2
SL-279252 (0.01 mg/kg S1)	1
SL-279252 (0.03 mg/kg S1)	2
SL-279252 (0.1 mg/kg S1)	3
SL-279252 (0.3 mg/kg S1 or S2)	8
SL-279252 (1.0 mg/kg S1 or S2)	12
SL-279252 (3.0 mg/kg S1 or S2)	9
SL-279252 (6.0 mg/kg S1)	4
SL-279252 (12.0 mg/kg S1)	4
SL-279252 (24.0 mg/kg S1)	2

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
SL-279252 (0.0001 mg/kg S1)	1
SL-279252 (0.001 mg/kg S1)	1
SL-279252 (0.003 mg/kg S1)	2
SL-279252 (0.01 mg/kg S1)	1
SL-279252 (0.03 mg/kg S1)	2
SL-279252 (0.1 mg/kg S1)	3
SL-279252 (0.3 mg/kg S1 or S2)	8
SL-279252 (1.0 mg/kg S1 or S2)	12
SL-279252 (3.0 mg/kg S1 or S2)	9
SL-279252 (6.0 mg/kg S1)	4
SL-279252 (12.0 mg/kg S1)	4
SL-279252 (24.0 mg/kg S1)	2

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
SL-279252 (0.0001 mg/kg S1)	NA	Not reported	NA	NA	Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
SL-279252 (0.001 mg/kg S1)	0.42	Not reported	0.42	0.42	Not reported
SL-279252 (0.003 mg/kg S1)	1.89	Not reported	0.25	3.53	Not reported
SL-279252 (0.01 mg/kg S1)	0.72	Not reported	0.72	0.72	Not reported
SL-279252 (0.03 mg/kg S1)	0.78	Not reported	0.57	1.00	Not reported
SL-279252 (0.1 mg/kg S1)	0.55	Not reported	0.53	0.67	Not reported
SL-279252 (0.3 mg/kg S1 or S2)	0.53	Not reported	0.50	1.13	Not reported
SL-279252 (1.0 mg/kg S1 or S2)	1.05	Not reported	0.58	1.52	Not reported
SL-279252 (3.0 mg/kg S1 or S2)	1.05	Not reported	0.98	1.40	Not reported
SL-279252 (6.0 mg/kg S1)	0.86	Not reported	0.58	1.07	Not reported
SL-279252 (12.0 mg/kg S1)	1.40	Not reported	0.93	1.78	Not reported
SL-279252 (24.0 mg/kg S1)	1.16	Not reported	1.02	1.30	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
SL-279252 (0.0001 mg/kg S1)	1
SL-279252 (0.001 mg/kg S1)	1
SL-279252 (0.003 mg/kg S1)	1
SL-279252 (0.01 mg/kg S1)	1
SL-279252 (0.03 mg/kg S1)	2
SL-279252 (0.1 mg/kg S1)	3
SL-279252 (0.3 mg/kg S1 or S2)	7
SL-279252 (1.0 mg/kg S1 or S2)	12
SL-279252 (3.0 mg/kg S1 or S2)	9
SL-279252 (6.0 mg/kg S1)	3
SL-279252 (12.0 mg/kg S1)	4
SL-279252 (24.0 mg/kg S1)	2

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
SL-279252 (0.0001 mg/kg S1)	NA	Not reported	NA	NA	Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
SL-279252 (0.001 mg/kg S1)	0.17	Not reported	0.17	0.17	Not reported
SL-279252 (0.003 mg/kg S1)	0.33	Not reported	0.33	0.33	Not reported
SL-279252 (0.01 mg/kg S1)	NA	Not reported	NA	NA	Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
SL-279252 (0.03 mg/kg S1)	0.50	Not reported	0.50	0.50	Not reported
SL-279252 (0.1 mg/kg S1)	0.50	Not reported	0.50	0.50	Not reported
SL-279252 (0.3 mg/kg S1 or S2)	0.50	Not reported	0.50	0.50	Not reported
SL-279252 (1.0 mg/kg S1 or S2)	1.00	Not reported	1.00	1.05	Not reported
SL-279252 (3.0 mg/kg S1 or S2)	1.00	Not reported	1.00	3.00	Not reported
SL-279252 (6.0 mg/kg S1)	1.00	Not reported	1.00	1.00	Not reported
SL-279252 (12.0 mg/kg S1)	1.00	Not reported	1.00	1.25	Not reported
SL-279252 (24.0 mg/kg S1)	1.00	Not reported	1.00	1.00	Not reported

Cycle 2 Day 1 (Schedule 1 only)

Analysis denominator · Participants

Group	Source count
SL-279252 (0.0001 mg/kg S1)	1
SL-279252 (0.001 mg/kg S1)	1
SL-279252 (0.003 mg/kg S1)	2
SL-279252 (0.01 mg/kg S1)	0
SL-279252 (0.03 mg/kg S1)	2
SL-279252 (0.1 mg/kg S1)	3
SL-279252 (0.3 mg/kg S1 or S2)	4
SL-279252 (1.0 mg/kg S1 or S2)	5
SL-279252 (3.0 mg/kg S1 or S2)	5
SL-279252 (6.0 mg/kg S1)	2
SL-279252 (12.0 mg/kg S1)	4
SL-279252 (24.0 mg/kg S1)	2

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
SL-279252 (0.0001 mg/kg S1)	NA	Not reported	NA	NA	Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
SL-279252 (0.001 mg/kg S1)	NA	Not reported	NA	NA	Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
SL-279252 (0.003 mg/kg S1)	0.38	Not reported	0.27	0.50	Not reported
SL-279252 (0.03 mg/kg S1)	0.55	Not reported	0.52	0.58	Not reported
SL-279252 (0.1 mg/kg S1)	0.58	Not reported	0.53	0.60	Not reported
SL-279252 (0.3 mg/kg S1 or S2)	0.54	Not reported	0.42	0.58	Not reported
SL-279252 (1.0 mg/kg S1 or S2)	1.05	Not reported	0.58	1.38	Not reported
SL-279252 (3.0 mg/kg S1 or S2)	1.38	Not reported	1.02	3.02	Not reported
SL-279252 (6.0 mg/kg S1)	1.00	Not reported	0.95	1.05	Not reported
SL-279252 (12.0 mg/kg S1)	1.17	Not reported	1.08	1.30	Not reported
SL-279252 (24.0 mg/kg S1)	1.08	Not reported	1.05	1.12	Not reported

Cycle 2 Day 1 (Schedule 2 only)

Analysis denominator · Participants

Group	Source count
SL-279252 (0.0001 mg/kg S1)	0
SL-279252 (0.001 mg/kg S1)	0
SL-279252 (0.003 mg/kg S1)	0
SL-279252 (0.01 mg/kg S1)	0
SL-279252 (0.03 mg/kg S1)	0
SL-279252 (0.1 mg/kg S1)	0
SL-279252 (0.3 mg/kg S1 or S2)	3
SL-279252 (1.0 mg/kg S1 or S2)	6
SL-279252 (3.0 mg/kg S1 or S2)	3
SL-279252 (6.0 mg/kg S1)	0
SL-279252 (12.0 mg/kg S1)	0
SL-279252 (24.0 mg/kg S1)	0

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
SL-279252 (0.3 mg/kg S1 or S2)	0.70	Not reported	0.53	0.88	Not reported
SL-279252 (1.0 mg/kg S1 or S2)	1.04	Not reported	1.02	1.08	Not reported
SL-279252 (3.0 mg/kg S1 or S2)	1.03	Not reported	1.03	1.03	Not reported

Complete source fields

classes

categories
measurements
comment
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
0.42
upper Limit
0.42
value
0.42
group Id
OG002
lower Limit
0.25
upper Limit
3.53
value
1.89
group Id
OG003
lower Limit
0.72
upper Limit
0.72
value
0.72
group Id
OG004
lower Limit
0.57
upper Limit
1.00
value
0.78
group Id
OG005
lower Limit
0.53
upper Limit
0.67
value
0.55
group Id
OG006
lower Limit
0.50
upper Limit
1.13
value
0.53
group Id
OG007
lower Limit
0.58
upper Limit
1.52
value
1.05
group Id
OG008
lower Limit
0.98
upper Limit
1.40
value
1.05
group Id
OG009
lower Limit
0.58
upper Limit
1.07
value
0.86
group Id
OG010
lower Limit
0.93
upper Limit
1.78
value
1.40
group Id
OG011
lower Limit
1.02
upper Limit
1.30
value
1.16
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
8
group Id
OG007
value
12
group Id
OG008
value
9
group Id
OG009
value
4
group Id
OG010
value
4
group Id
OG011
value
2
units
Participants
title
Cycle 1 Day 1
categories
measurements
comment
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
0.17
upper Limit
0.17
value
0.17
group Id
OG002
lower Limit
0.33
upper Limit
0.33
value
0.33
comment
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG004
lower Limit
0.50
upper Limit
0.50
value
0.50
group Id
OG005
lower Limit
0.50
upper Limit
0.50
value
0.50
group Id
OG006
lower Limit
0.50
upper Limit
0.50
value
0.50
group Id
OG007
lower Limit
1.00
upper Limit
1.05
value
1.00
group Id
OG008
lower Limit
1.00
upper Limit
3.00
value
1.00
group Id
OG009
lower Limit
1.00
upper Limit
1.00
value
1.00
group Id
OG010
lower Limit
1.00
upper Limit
1.25
value
1.00
group Id
OG011
lower Limit
1.00
upper Limit
1.00
value
1.00
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
2
group Id
OG005
value
3
group Id
OG006
value
7
group Id
OG007
value
12
group Id
OG008
value
9
group Id
OG009
value
3
group Id
OG010
value
4
group Id
OG011
value
2
units
Participants
title
Cycle 1 Day 15
categories
measurements
comment
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG002
lower Limit
0.27
upper Limit
0.50
value
0.38
group Id
OG004
lower Limit
0.52
upper Limit
0.58
value
0.55
group Id
OG005
lower Limit
0.53
upper Limit
0.60
value
0.58
group Id
OG006
lower Limit
0.42
upper Limit
0.58
value
0.54
group Id
OG007
lower Limit
0.58
upper Limit
1.38
value
1.05
group Id
OG008
lower Limit
1.02
upper Limit
3.02
value
1.38
group Id
OG009
lower Limit
0.95
upper Limit
1.05
value
1.00
group Id
OG010
lower Limit
1.08
upper Limit
1.30
value
1.17
group Id
OG011
lower Limit
1.05
upper Limit
1.12
value
1.08
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
4
group Id
OG007
value
5
group Id
OG008
value
5
group Id
OG009
value
2
group Id
OG010
value
4
group Id
OG011
value
2
units
Participants
title
Cycle 2 Day 1 (Schedule 1 only)
categories
measurements
group Id
OG006
lower Limit
0.53
upper Limit
0.88
value
0.70
group Id
OG007
lower Limit
1.02
upper Limit
1.08
value
1.04
group Id
OG008
lower Limit
1.03
upper Limit
1.03
value
1.03
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
3
group Id
OG007
value
6
group Id
OG008
value
3
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
units
Participants
title
Cycle 2 Day 1 (Schedule 2 only)

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
3
group Id
OG006
value
8
group Id
OG007
value
12
group Id
OG008
value
9
group Id
OG009
value
4
group Id
OG010
value
4
group Id
OG011
value
2
units
Participants

description

The Tmax is the time at which the maximum concentration of SL-279252 is observed following single and multiple doses

dispersion Type

Full Range

groups

description
0.0001 mg/kg of IV SL-279252 (Schedule 1)
id
OG000
title
SL-279252 (0.0001 mg/kg S1)
description
0.001 mg/kg of IV SL-279252 (Schedule 1)
id
OG001
title
SL-279252 (0.001 mg/kg S1)
description
0.003 mg/kg of IV SL-279252 (Schedule 1)
id
OG002
title
SL-279252 (0.003 mg/kg S1)
description
0.01 mg/kg of IV SL-279252 (Schedule 1)
id
OG003
title
SL-279252 (0.01 mg/kg S1)
description
0.03 mg/kg of IV SL-279252 (Schedule 1)
id
OG004
title
SL-279252 (0.03 mg/kg S1)
description
0.1 mg/kg of IV SL-279252 (Schedule 1)
id
OG005
title
SL-279252 (0.1 mg/kg S1)
description
0.3 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
id
OG006
title
SL-279252 (0.3 mg/kg S1 or S2)
description
1.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
id
OG007
title
SL-279252 (1.0 mg/kg S1 or S2)
description
3.0 mg/kg of IV SL-279252 (Schedule 1 or Schedule 2)
id
OG008
title
SL-279252 (3.0 mg/kg S1 or S2)
description
6.0 mg/kg of IV SL-279252 (Schedule 1)
id
OG009
title
SL-279252 (6.0 mg/kg S1)
description
12.0 mg/kg of IV SL-279252 (Schedule 1)
id
OG010
title
SL-279252 (12.0 mg/kg S1)
description
24.0 mg/kg of IV SL-279252 (Schedule 1)
id
OG011
title
SL-279252 (24.0 mg/kg S1)

param Type

MEDIAN

population Description

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.

reporting Status

POSTED

time Frame

Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)

title

Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)

type

SECONDARY

unit Of Measure

hours

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice