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NCT02923349 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    title
    PART 1 Dose 7 (1400 mg)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        18
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        19
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment.
recruitment Details
The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    title
    PART 1 Dose 7 (1400 mg)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        18
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        19
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment.
recruitment Details
The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.

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

Preserved source evidence · Not medical advice