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NCT02903914 · FLOW

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Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

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

groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    FG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    FG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    FG002
    title
    Part 1A and Part 2: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    FG003
    title
    Part 1A: INCB001158 150 mg
  5. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
    id
    FG004
    title
    Part 1B: INCB001158 50 mg + Pembrolizumab
  6. description
    INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    FG005
    title
    Part 1B: INCB001158 75 mg + Pembrolizumab
  7. description
    INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    FG006
    title
    Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
  8. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
    id
    FG007
    title
    Part 1C: INCB001158 50 mg + Pembrolizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        12
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        2
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Symptomatic Deterioration
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        56
      8. group Id
        FG007
        num Subjects
        3
      type
      New Cancer Therapy
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      type
      Didn't Return to Site
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        0
      type
      Entered/Referred to Hospice Care
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        0
      type
      Follow-up Did Not Occur
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Systemic Treatment Options Necessary
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        85
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        123
      8. group Id
        FG007
        num Subjects
        6
      type
      STARTED
    2. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        85
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        123
      8. group Id
        FG007
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
260 enrolled participants: 107 in the Part 1a and Part 2 monotherapy groups; 147 in the Part 1b and Part 3 combination therapy groups; and 6 in Part 1c. Disposition data have been reported by dose level; efficacy data have been reported by tumor type, regardless of dose received. One Part 3 participant scheduled to receive INCB001158 100 mg actually received 75 mg; they were included in the Part 1b 75 mg arm for disposition analysis and in the Part 1c and Part 3 100 mg arm for efficacy analysis.
recruitment Details
This global study (United States, Spain, and Italy) consisted of 3 parts: Part 1 was dose-escalation using a 3 + 3 design to determine the RP2D of INCB001158 as monotherapy (Part 1a) and in combination with pembrolizumab (Parts 1b and 1c); Part 2 and Part 3 consisted of tumor expansion cohorts to determine whether INCB001158 as monotherapy (Part 2) or in combination with pembrolizumab (Part 3) had sufficient antitumor activity and further evaluated the safety and tolerability of the RP2D.
Complete source fields
groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    FG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    FG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    FG002
    title
    Part 1A and Part 2: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    FG003
    title
    Part 1A: INCB001158 150 mg
  5. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
    id
    FG004
    title
    Part 1B: INCB001158 50 mg + Pembrolizumab
  6. description
    INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    FG005
    title
    Part 1B: INCB001158 75 mg + Pembrolizumab
  7. description
    INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    FG006
    title
    Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
  8. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
    id
    FG007
    title
    Part 1C: INCB001158 50 mg + Pembrolizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        12
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        2
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Symptomatic Deterioration
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        56
      8. group Id
        FG007
        num Subjects
        3
      type
      New Cancer Therapy
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      type
      Didn't Return to Site
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        0
      type
      Entered/Referred to Hospice Care
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        0
      type
      Follow-up Did Not Occur
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Systemic Treatment Options Necessary
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        85
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        123
      8. group Id
        FG007
        num Subjects
        6
      type
      STARTED
    2. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        85
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        123
      8. group Id
        FG007
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
260 enrolled participants: 107 in the Part 1a and Part 2 monotherapy groups; 147 in the Part 1b and Part 3 combination therapy groups; and 6 in Part 1c. Disposition data have been reported by dose level; efficacy data have been reported by tumor type, regardless of dose received. One Part 3 participant scheduled to receive INCB001158 100 mg actually received 75 mg; they were included in the Part 1b 75 mg arm for disposition analysis and in the Part 1c and Part 3 100 mg arm for efficacy analysis.
recruitment Details
This global study (United States, Spain, and Italy) consisted of 3 parts: Part 1 was dose-escalation using a 3 + 3 design to determine the RP2D of INCB001158 as monotherapy (Part 1a) and in combination with pembrolizumab (Parts 1b and 1c); Part 2 and Part 3 consisted of tumor expansion cohorts to determine whether INCB001158 as monotherapy (Part 2) or in combination with pembrolizumab (Part 3) had sufficient antitumor activity and further evaluated the safety and tolerability of the RP2D.

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