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NCT03606174 · FLOW

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A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma · Source last updated 2023-08-24

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

groups
  1. description
    Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).
    id
    FG000
    title
    Cohort 1
  2. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG001
    title
    Cohort 2
  3. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG002
    title
    Cohort 3
  4. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG003
    title
    Cohort 4
  5. description
    Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG004
    title
    Cohort 5
  6. description
    Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG005
    title
    Cohort 6
  7. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG006
    title
    Cohort 7
  8. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG007
    title
    Cohort 8
  9. description
    Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.
    id
    FG008
    title
    Cohort 9 Dose Level 1
  10. description
    Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
    id
    FG009
    title
    Cohort 9 Dose Level 2
  11. description
    Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
    id
    FG010
    title
    Cohort 9 Dose Level 3
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        35
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        35
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        0
      type
      Death
    2. 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
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      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
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        12
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      type
      Study Terminated by Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        53
      6. group Id
        FG005
        num Subjects
        27
      7. group Id
        FG006
        num Subjects
        56
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. comment
        N/A for Cohorts 1-8
        group Id
        FG000
        num Subjects
        0
      2. comment
        N/A for Cohorts 1-8
        group Id
        FG001
        num Subjects
        0
      3. comment
        N/A for Cohorts 1-8
        group Id
        FG002
        num Subjects
        0
      4. comment
        N/A for Cohorts 1-8
        group Id
        FG003
        num Subjects
        0
      5. comment
        N/A for Cohorts 1-8
        group Id
        FG004
        num Subjects
        0
      6. comment
        N/A for Cohorts 1-8
        group Id
        FG005
        num Subjects
        0
      7. comment
        N/A for Cohorts 1-8
        group Id
        FG006
        num Subjects
        0
      8. comment
        N/A for Cohorts 1-8
        group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        4
      type
      Started Cohort 9 Lead-in Dose-escalation Part
    3. achievements
      1. comment
        N/A for Cohorts 1-8
        group Id
        FG000
        num Subjects
        0
      2. comment
        N/A for Cohorts 1-8
        group Id
        FG001
        num Subjects
        0
      3. comment
        N/A for Cohorts 1-8
        group Id
        FG002
        num Subjects
        0
      4. comment
        N/A for Cohorts 1-8
        group Id
        FG003
        num Subjects
        0
      5. comment
        N/A for Cohorts 1-8
        group Id
        FG004
        num Subjects
        0
      6. comment
        N/A for Cohorts 1-8
        group Id
        FG005
        num Subjects
        0
      7. comment
        N/A for Cohorts 1-8
        group Id
        FG006
        num Subjects
        0
      8. comment
        N/A for Cohorts 1-8
        group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Started Cohort 9 Dose-expansion Part
    4. 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
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        53
      6. group Id
        FG005
        num Subjects
        27
      7. group Id
        FG006
        num Subjects
        56
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Screening tests and procedures were performed within the 28 days preceding administration of the first dose.
recruitment Details
260 participants were enrolled into this study at investigative sites in the United States.
Complete source fields
groups
  1. description
    Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).
    id
    FG000
    title
    Cohort 1
  2. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG001
    title
    Cohort 2
  3. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG002
    title
    Cohort 3
  4. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG003
    title
    Cohort 4
  5. description
    Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG004
    title
    Cohort 5
  6. description
    Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG005
    title
    Cohort 6
  7. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG006
    title
    Cohort 7
  8. description
    Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.
    id
    FG007
    title
    Cohort 8
  9. description
    Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.
    id
    FG008
    title
    Cohort 9 Dose Level 1
  10. description
    Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
    id
    FG009
    title
    Cohort 9 Dose Level 2
  11. description
    Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
    id
    FG010
    title
    Cohort 9 Dose Level 3
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        35
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        35
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        0
      type
      Death
    2. 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
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      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
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        12
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      type
      Study Terminated by Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        53
      6. group Id
        FG005
        num Subjects
        27
      7. group Id
        FG006
        num Subjects
        56
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. comment
        N/A for Cohorts 1-8
        group Id
        FG000
        num Subjects
        0
      2. comment
        N/A for Cohorts 1-8
        group Id
        FG001
        num Subjects
        0
      3. comment
        N/A for Cohorts 1-8
        group Id
        FG002
        num Subjects
        0
      4. comment
        N/A for Cohorts 1-8
        group Id
        FG003
        num Subjects
        0
      5. comment
        N/A for Cohorts 1-8
        group Id
        FG004
        num Subjects
        0
      6. comment
        N/A for Cohorts 1-8
        group Id
        FG005
        num Subjects
        0
      7. comment
        N/A for Cohorts 1-8
        group Id
        FG006
        num Subjects
        0
      8. comment
        N/A for Cohorts 1-8
        group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        4
      type
      Started Cohort 9 Lead-in Dose-escalation Part
    3. achievements
      1. comment
        N/A for Cohorts 1-8
        group Id
        FG000
        num Subjects
        0
      2. comment
        N/A for Cohorts 1-8
        group Id
        FG001
        num Subjects
        0
      3. comment
        N/A for Cohorts 1-8
        group Id
        FG002
        num Subjects
        0
      4. comment
        N/A for Cohorts 1-8
        group Id
        FG003
        num Subjects
        0
      5. comment
        N/A for Cohorts 1-8
        group Id
        FG004
        num Subjects
        0
      6. comment
        N/A for Cohorts 1-8
        group Id
        FG005
        num Subjects
        0
      7. comment
        N/A for Cohorts 1-8
        group Id
        FG006
        num Subjects
        0
      8. comment
        N/A for Cohorts 1-8
        group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Started Cohort 9 Dose-expansion Part
    4. 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
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        53
      6. group Id
        FG005
        num Subjects
        27
      7. group Id
        FG006
        num Subjects
        56
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Screening tests and procedures were performed within the 28 days preceding administration of the first dose.
recruitment Details
260 participants were enrolled into this study at investigative sites in the United States.

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Preserved source evidence · Not medical advice