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NCT06039384 · OUTCOME

Number of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation of INCB099280 and Adagarsib

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 574 days

What was measured

An AE was defined any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or start of new anticancer therapy.

Analysis population: Safety 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

Participants with TEAEs leading to dose interruption of INCB099280
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID2Not reportedNot reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
Participants with TEAEs leading to dose reduction of INCB099280
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
Participants with TEAEs leading to discontinuation of INCB099280
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
Participants with TEAEs leading to dose interruption of adagrasib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID2Not reportedNot reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
Participants with TEAEs leading to dose reduction of adagrasib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID1Not reportedNot reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID1Not reportedNot reportedNot reportedNot reported
Participants with TEAEs leading to discontinuation of adagrasib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB099280 50 mg QD Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
INCB099280 100 mg BID Plus Adagrasib 400 mg BID0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Participants with TEAEs leading to dose interruption of INCB099280
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Participants with TEAEs leading to dose reduction of INCB099280
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Participants with TEAEs leading to discontinuation of INCB099280
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Participants with TEAEs leading to dose interruption of adagrasib
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Participants with TEAEs leading to dose reduction of adagrasib
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Participants with TEAEs leading to discontinuation of adagrasib
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
An AE was defined any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or start of new anticancer therapy.
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
COUNT_OF_PARTICIPANTS
population Description
Safety Population
reporting Status
POSTED
time Frame
up to 574 days
title
Number of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation of INCB099280 and Adagarsib
type
PRIMARY
unit Of Measure
Participants

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

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