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NCT02923349 · OUTCOME

Duration of Response Per RECIST and Modified RECIST

A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors · Source last updated 2025-08-24

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Baseline and every 8 weeks, up to 11 months

What was measured

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.

Analysis population: The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response

Groups in this outcome

PART 1 Dose 1 (7 mg)

INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 2 (20 mg)

INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 3 (70 mg)

INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 4 (200 mg)

INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 5 (350 mg)

INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 6 (700 mg)

INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 7 (1400 mg)

INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

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 Dose 1 (7 mg)0
PART 1 Dose 2 (20 mg)0
PART 1 Dose 3 (70 mg)0
PART 1 Dose 4 (200 mg)0
PART 1 Dose 5 (350 mg)0
PART 1 Dose 6 (700 mg)1
PART 1 Dose 7 (1400 mg)0

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PART 1 Dose 6 (700 mg)192192192192Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG005
        lower Limit
        192
        spread
        192
        upper Limit
        192
        value
        192
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    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
      1
    7. group Id
      OG006
      value
      0
    units
    Participants
description
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
dispersion Type
Full Range
groups
  1. description
    INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG000
    title
    PART 1 Dose 1 (7 mg)
  2. description
    INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG001
    title
    PART 1 Dose 2 (20 mg)
  3. description
    INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG002
    title
    PART 1 Dose 3 (70 mg)
  4. description
    INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG003
    title
    PART 1 Dose 4 (200 mg)
  5. description
    INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG004
    title
    PART 1 Dose 5 (350 mg)
  6. description
    INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG005
    title
    PART 1 Dose 6 (700 mg)
  7. description
    INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
    id
    OG006
    title
    PART 1 Dose 7 (1400 mg)
param Type
MEDIAN
population Description
The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response
reporting Status
POSTED
time Frame
Baseline and every 8 weeks, up to 11 months
title
Duration of Response Per RECIST and Modified RECIST
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice