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NCT03621982 · FLOW

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Study of ADCT-301 in Patients With Selected Advanced Solid Tumors · Source last updated 2024-06-13

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

groups
  1. description
    Participants received 20 µg/kg ADCT-301 every 3 weeks (Q3W), intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    FG000
    title
    ADCT-301 Monotherapy 20 µg/kg
  2. description
    Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG001
    title
    ADCT-301 Monotherapy 30 µg/kg
  3. description
    Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG002
    title
    ADCT-301 Monotherapy 45 µg/kg
  4. description
    Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG003
    title
    ADCT-301 Monotherapy 60 µg/kg
  5. description
    Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG004
    title
    ADCT-301 Monotherapy 80 µg/kg
  6. description
    Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG005
    title
    ADCT-301 Monotherapy 100 µg/kg
  7. description
    Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG006
    title
    ADCT-301 Monotherapy 125 µg/kg
  8. description
    Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG007
    title
    ADCT-301 Monotherapy 150 µg/kg
  9. description
    Participants received 20 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG008
    title
    ADCT-301 Combination Therapy 20 µg/kg + Pembrolizamab (Pemb)
  10. description
    Participants received 30 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG009
    title
    ADCT-301 Combination Therapy 30 µg/kg + Pemb
  11. description
    Participants received 45 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG010
    title
    ADCT-301 Combination Therapy 45 µg/kg + Pemb
  12. description
    Participants received 60 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG011
    title
    ADCT-301 Combination Therapy 60 µg/kg + Pemb
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        1
      type
      Withdrawal by Subject
    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
        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
      12. group Id
        FG011
        num Subjects
        4
      type
      Investigator/Sponsor decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        8
      12. group Id
        FG011
        num Subjects
        4
      type
      Death
    4. 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
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        10
      12. group Id
        FG011
        num Subjects
        9
      type
      STARTED
    2. achievements
      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
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      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
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        10
      12. group Id
        FG011
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In part 1, participants were to receive escalating doses of camidanlumab tesirine as monotherapy or escalating doses of camidanlumab tesirine in combination with pembrolizumab, guided by a 3+3 design. The study was terminated prior to enrollment for Part 2 of the study.
recruitment Details
Participants were enrolled at 9 study centers in 3 countries, including the United States, Belgium, and the United Kingdom, from November 2018 to December 2022.
Complete source fields
groups
  1. description
    Participants received 20 µg/kg ADCT-301 every 3 weeks (Q3W), intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    FG000
    title
    ADCT-301 Monotherapy 20 µg/kg
  2. description
    Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG001
    title
    ADCT-301 Monotherapy 30 µg/kg
  3. description
    Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG002
    title
    ADCT-301 Monotherapy 45 µg/kg
  4. description
    Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG003
    title
    ADCT-301 Monotherapy 60 µg/kg
  5. description
    Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG004
    title
    ADCT-301 Monotherapy 80 µg/kg
  6. description
    Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG005
    title
    ADCT-301 Monotherapy 100 µg/kg
  7. description
    Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG006
    title
    ADCT-301 Monotherapy 125 µg/kg
  8. description
    Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    FG007
    title
    ADCT-301 Monotherapy 150 µg/kg
  9. description
    Participants received 20 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG008
    title
    ADCT-301 Combination Therapy 20 µg/kg + Pembrolizamab (Pemb)
  10. description
    Participants received 30 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG009
    title
    ADCT-301 Combination Therapy 30 µg/kg + Pemb
  11. description
    Participants received 45 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG010
    title
    ADCT-301 Combination Therapy 45 µg/kg + Pemb
  12. description
    Participants received 60 µg/kg ADCT-301 Q3W, IV and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    FG011
    title
    ADCT-301 Combination Therapy 60 µg/kg + Pemb
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        1
      type
      Withdrawal by Subject
    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
        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
      12. group Id
        FG011
        num Subjects
        4
      type
      Investigator/Sponsor decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        8
      12. group Id
        FG011
        num Subjects
        4
      type
      Death
    4. 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
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        10
      12. group Id
        FG011
        num Subjects
        9
      type
      STARTED
    2. achievements
      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
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      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
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        10
      12. group Id
        FG011
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In part 1, participants were to receive escalating doses of camidanlumab tesirine as monotherapy or escalating doses of camidanlumab tesirine in combination with pembrolizumab, guided by a 3+3 design. The study was terminated prior to enrollment for Part 2 of the study.
recruitment Details
Participants were enrolled at 9 study centers in 3 countries, including the United States, Belgium, and the United Kingdom, from November 2018 to December 2022.

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Preserved source evidence · Not medical advice