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NCT06024174 · OUTCOME

Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors · Source last updated 2025-07-22

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

Measure
GEOMETRIC_MEAN
Unit
mcg*hr/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 (Each cycle consist of 28 days)

What was measured

Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.

Analysis population: Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only.

Groups in this outcome

Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID

Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.

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

Analysis denominator · Participants

GroupSource count
Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID5

Reported measurements

Source class 1
Values in mcg*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BIDNANANot reportedNot reportedNo participants had adequate PK profiles (below lower limit of quantification).
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        No participants had adequate PK profiles (below lower limit of quantification).
        group Id
        OG000
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
    id
    OG000
    title
    Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (Each cycle consist of 28 days)
title
Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])
type
SECONDARY
unit Of Measure
mcg*hr/mL

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

Preserved source evidence · Not medical advice