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NCT00819169 · OUTCOME

Objective Response Rate

QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors · Source last updated 2024-08-20

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
Time from first dose up to 24 months

What was measured

The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: A subject was included in the analysis if they received at least one dose of study drug.

Groups in this outcome

Part 1 Cohort 1

AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Part 1 Cohort 2

AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Part 1 Cohort 3

AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.

Part 2 Cohort 1

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC

Part 2 Cohort 2

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)

Part 2 Cohort 3

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)

Part 2 Cohort 4

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer

Part 2 Cohort 5

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer

Part 2 Cohort 6

AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma

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 Cohort 13
Part 1 Cohort 23
Part 1 Cohort 33
Part 2 Cohort 115
Part 2 Cohort 27
Part 2 Cohort 316
Part 2 Cohort 416
Part 2 Cohort 59
Part 2 Cohort 615

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Cohort 11Not reportedNot reportedNot reportedNot reported
Part 1 Cohort 20Not reportedNot reportedNot reportedNot reported
Part 1 Cohort 30Not reportedNot reportedNot reportedNot reported
Part 2 Cohort 10Not reportedNot reportedNot reportedNot reported
Part 2 Cohort 20Not reportedNot reportedNot reportedNot reported
Part 2 Cohort 30Not reportedNot reportedNot reportedNot reported
Part 2 Cohort 40Not reportedNot reportedNot reportedNot reported
Part 2 Cohort 50Not reportedNot reportedNot reportedNot reported
Part 2 Cohort 60Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      15
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      16
    7. group Id
      OG006
      value
      16
    8. group Id
      OG007
      value
      9
    9. group Id
      OG008
      value
      15
    units
    Participants
description
The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
groups
  1. description
    AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    OG000
    title
    Part 1 Cohort 1
  2. description
    AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    OG001
    title
    Part 1 Cohort 2
  3. description
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
    id
    OG002
    title
    Part 1 Cohort 3
  4. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
    id
    OG003
    title
    Part 2 Cohort 1
  5. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
    id
    OG004
    title
    Part 2 Cohort 2
  6. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
    id
    OG005
    title
    Part 2 Cohort 3
  7. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
    id
    OG006
    title
    Part 2 Cohort 4
  8. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
    id
    OG007
    title
    Part 2 Cohort 5
  9. description
    AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
    id
    OG008
    title
    Part 2 Cohort 6
param Type
COUNT_OF_PARTICIPANTS
population Description
A subject was included in the analysis if they received at least one dose of study drug.
reporting Status
POSTED
time Frame
Time from first dose up to 24 months
title
Objective Response Rate
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice