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NCT06039384 · OUTCOME

AUC0-tau of INCB099280 When Administered Alone and in Combination With Adagrasib

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
hours x nmol/L
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter

What was measured

During the lead-in period, INCB099280 was administered as monotherapy. During the treatment period, INCB099280 and adagrasib were coadministered. AUC0-tau was defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval of INCB099280. 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, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.

Analysis population: PK-Evaluable Population

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

GroupSource count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID3

Reported measurements

INCB099280 alone

Analysis denominator · Participants

GroupSource count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID2
Values in hours x nmol/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID3359.89Not reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID251027.7Not reportedNot reportedNot reported
INCB099280 administered with adagrasib

Analysis denominator · Participants

GroupSource count
INCB099280 50 mg QD Plus Adagrasib 400 mg BID3
INCB099280 100 mg BID Plus Adagrasib 400 mg BID3
Values in hours x nmol/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID96377.4Not reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID814082.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.89
        value
        335
      2. group Id
        OG001
        spread
        27.7
        value
        2510
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    INCB099280 alone
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        77.4
        value
        963
      2. group Id
        OG001
        spread
        82.0
        value
        8140
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    INCB099280 administered with adagrasib
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. 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. AUC0-tau was defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval of INCB099280. 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, 6, 8, 12, and every fourth cycle thereafter. Without Lead-in Period: Cycle 1 Day 8: predose and 1, 2, and 4 hours postdose; predose on Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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
  2. 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
PK-Evaluable Population
reporting Status
POSTED
time Frame
Day -1; Cycle 1 Day 8; Day 1 of Cycles 1, 2, 4, 6, 8, 12, and every fourth cycle thereafter
title
AUC0-tau of INCB099280 When Administered Alone and in Combination With Adagrasib
type
SECONDARY
unit Of Measure
hours x nmol/L

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

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