Skip to content

TriangleGet started

← Full study record

NCT06039384 · OUTCOME

Concentration of INCB099280

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation · Source last updated 2026-09-08

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

Measure: GEOMETRIC_MEAN
Unit: nanomoles (nM)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Lead-in Period Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, and 6

What was measured

During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered.

Analysis population: Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of INCB099280 and provided at least 1 postbaseline plasma sample (1 PK measurement)

Groups in this outcome

INCB099280 50 mg QD Plus Adagrasib 400 mg BID

Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.

INCB099280 100 mg BID Plus Adagrasib 400 mg BID

Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.

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
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Reported measurements

Lead-in Period Day -1, predose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	7.06	47.6	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	138	19.3	Not reported	Not reported	Not reported

Lead-in Period Day -1, 0.5 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	8.77	38.1	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	147	26.0	Not reported	Not reported	Not reported

Lead-in Period Day -1, 1 hour postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	14.5	22.4	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	155	22.9	Not reported	Not reported	Not reported

Lead-in Period Day -1, 2 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	20.8	23.8	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	211	67.1	Not reported	Not reported	Not reported

Lead-in Period Day -1, 3 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	25.5	6.56	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	246	56.8	Not reported	Not reported	Not reported

Lead-in Period Day -1, 4 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	24.9	13.1	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	231	45.3	Not reported	Not reported	Not reported

Lead-in Period Day -1, 5 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	8.77	38.1	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	147	26.0	Not reported	Not reported	Not reported

Lead-in Period Day -1, 6 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	22.1	23.2	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	223	55.1	Not reported	Not reported	Not reported

Lead-in Period Day -1, 8 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	14.9	5.81	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	168	6.31	Not reported	Not reported	Not reported

Lead-in Period Day -1, 12 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	12.4	12.8	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	130	9.84	Not reported	Not reported	Not reported

Lead-in Period Day -1, 24 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	0

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	7.57	27.4	Not reported	Not reported	Not reported

Cycle 1 Day 1, predose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	0
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	147	93.0	Not reported	Not reported	Not reported

Cycle 1 Day 8, predose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	14.1	106	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	714	85.5	Not reported	Not reported	Not reported

Cycle 1 Day 8, 0.5 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	17.8	254	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	620	58.3	Not reported	Not reported	Not reported

Cycle 1 Day 8, 1 hour postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	23.0	307	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	637	59.9	Not reported	Not reported	Not reported

Cycle 1 Day 8, 2 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	43.2	161	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	868	86.9	Not reported	Not reported	Not reported

Cycle 1 Day 8, 3 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	71.7	98.4	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	807	89.6	Not reported	Not reported	Not reported

Cycle 1 Day 8, 4 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	73.6	92.2	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	814	77.1	Not reported	Not reported	Not reported

Cycle 1 Day 8, 5 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	17.8	254	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	620	58.3	Not reported	Not reported	Not reported

Cycle 1 Day 8, 6 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	68.9	72.9	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	792	81.3	Not reported	Not reported	Not reported

Cycle 1 Day 8, 8 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	55.8	46.9	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	530	82.8	Not reported	Not reported	Not reported

Cycle 1 Day 8, 12 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	3

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	43.6	58.3	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	569	97.5	Not reported	Not reported	Not reported

Cycle 1 Day 8, 24 hours postdose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	0

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	14.1	106	Not reported	Not reported	Not reported

Cycle 2 Day 1, predose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	2
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	1

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	40.2	43.8	Not reported	Not reported	Not reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	443	NA	Not reported	Not reported	The geometric coefficient of variation was not calculated for a single participant.

Cycle 4 Day 1, predose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	2
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	0

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	53.3	NA	Not reported	Not reported	One of the 2 observations was below the limit of quantification. Geometric coefficient of variation could not be calculated from a single measurable observation.

Cycle 6 Day 1, predose

Analysis denominator · Participants

Group	Source count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	1
INCB099280 100 mg BID Plus Adagrasib 400 mg BID	0

Values in nanomoles (nM) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID	25.1	NA	Not reported	Not reported	The geometric coefficient of variation was not calculated for a single participant.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
47.6
value
7.06
group Id
OG001
spread
19.3
value
138
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, predose
categories
measurements
group Id
OG000
spread
38.1
value
8.77
group Id
OG001
spread
26.0
value
147
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 0.5 hours postdose
categories
measurements
group Id
OG000
spread
22.4
value
14.5
group Id
OG001
spread
22.9
value
155
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 1 hour postdose
categories
measurements
group Id
OG000
spread
23.8
value
20.8
group Id
OG001
spread
67.1
value
211
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 2 hours postdose
categories
measurements
group Id
OG000
spread
6.56
value
25.5
group Id
OG001
spread
56.8
value
246
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 3 hours postdose
categories
measurements
group Id
OG000
spread
13.1
value
24.9
group Id
OG001
spread
45.3
value
231
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 4 hours postdose
categories
measurements
group Id
OG000
spread
38.1
value
8.77
group Id
OG001
spread
26.0
value
147
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 5 hours postdose
categories
measurements
group Id
OG000
spread
23.2
value
22.1
group Id
OG001
spread
55.1
value
223
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 6 hours postdose
categories
measurements
group Id
OG000
spread
5.81
value
14.9
group Id
OG001
spread
6.31
value
168
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 8 hours postdose
categories
measurements
group Id
OG000
spread
12.8
value
12.4
group Id
OG001
spread
9.84
value
130
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Lead-in Period Day -1, 12 hours postdose
categories
measurements
group Id
OG000
spread
27.4
value
7.57
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
units
Participants
title
Lead-in Period Day -1, 24 hours postdose
categories
measurements
group Id
OG001
spread
93.0
value
147
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
3
units
Participants
title
Cycle 1 Day 1, predose

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants

description

During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received INCB099280 50 milligrams (mg) once daily (QD) plus adagrasib 400 mg twice daily (BID) for up to 2 years.
id
OG000
title
INCB099280 50 mg QD Plus Adagrasib 400 mg BID
description
Participants received INCB099280 100 mg BID plus adagrasib 400 mg BID for up to 2 years.
id
OG001
title
INCB099280 100 mg BID Plus Adagrasib 400 mg BID

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of INCB099280 and provided at least 1 postbaseline plasma sample (1 PK measurement)

reporting Status

POSTED

time Frame

Lead-in Period Day -1 and Cycle 1 Day 8: predose and 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose; predose on Day 1 of Cycles 1, 2, 4, and 6

title

Concentration of INCB099280

type

SECONDARY

unit Of Measure

nanomoles (nM)

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

Preserved source evidence · Independent clinical review pending · Not medical advice