NCT02903914 · OUTCOME

Cmax of INCB001158 Following Single Escalating Doses for Part 1A

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

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

Measure: GEOMETRIC_MEAN
Unit: nanograms per milliliter (ng/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

What was measured

Cmax was defined as the maximum observed concentration of INCB001158.

Analysis population: Pharmacokinetic (PK) Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab and contributed at least 1 PK sample

Groups in this outcome

Part 1A: INCB001158 50 mg

INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 75 mg

INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 150 mg

INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.

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
Part 1A: INCB001158 50 mg	8
Part 1A: INCB001158 75 mg	7
Part 1A: INCB001158 100 mg	8
Part 1A: INCB001158 150 mg	7

Reported measurements

Source class 1

Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1A: INCB001158 50 mg	763	0.30	Not reported	Not reported	Not reported
Part 1A: INCB001158 75 mg	1310	0.26	Not reported	Not reported	Not reported
Part 1A: INCB001158 100 mg	1420	0.30	Not reported	Not reported	Not reported
Part 1A: INCB001158 150 mg	1990	0.33	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG000
OG001
OG002
OG003
non Inferiority Type
OTHER
p Value
0.0731
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
ci Lower Limit
0.784
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.110
group Ids
OG002
OG003
non Inferiority Type
OTHER
param Type
pairwise geometric mean ratio (GMR)
param Value
0.933
ci Lower Limit
0.908
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.271
group Ids
OG000
OG002
non Inferiority Type
OTHER
param Type
pairwise GMR
param Value
1.074
ci Lower Limit
1.034
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.463
group Ids
OG001
OG002
non Inferiority Type
OTHER
param Type
pairwise GMR
param Value
1.230

Complete source fields

analyses

group Ids
OG000
OG001
OG002
OG003
non Inferiority Type
OTHER
p Value
0.0731
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
ci Lower Limit
0.784
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.110
group Ids
OG002
OG003
non Inferiority Type
OTHER
param Type
pairwise geometric mean ratio (GMR)
param Value
0.933
ci Lower Limit
0.908
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.271
group Ids
OG000
OG002
non Inferiority Type
OTHER
param Type
pairwise GMR
param Value
1.074
ci Lower Limit
1.034
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.463
group Ids
OG001
OG002
non Inferiority Type
OTHER
param Type
pairwise GMR
param Value
1.230

classes

categories
measurements
group Id
OG000
spread
0.30
value
763
group Id
OG001
spread
0.26
value
1310
group Id
OG002
spread
0.30
value
1420
group Id
OG003
spread
0.33
value
1990

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
7
group Id
OG002
value
8
group Id
OG003
value
7
units
Participants

description

Cmax was defined as the maximum observed concentration of INCB001158.

dispersion Type

Geometric Coefficient of Variation

groups

description
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
id
OG000
title
Part 1A: INCB001158 50 mg
description
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
id
OG001
title
Part 1A: INCB001158 75 mg
description
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
id
OG002
title
Part 1A: INCB001158 100 mg
description
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
id
OG003
title
Part 1A: INCB001158 150 mg

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic (PK) Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab and contributed at least 1 PK sample

reporting Status

POSTED

time Frame

Cycle 1 Day 1: predose; 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

title

Cmax of INCB001158 Following Single Escalating Doses for Part 1A

type

SECONDARY

unit Of Measure

nanograms per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice