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NCT04306900 · FLOW

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TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers · Source last updated 2025-07-29

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

groups
  1. description
    Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG000
    title
    Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
  2. description
    Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG001
    title
    Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
  3. description
    Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG002
    title
    Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
  4. description
    Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG003
    title
    Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
  5. description
    Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG004
    title
    Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
  6. description
    Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    FG005
    title
    Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
  7. description
    Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    FG006
    title
    Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
  8. description
    Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG007
    title
    Cohort 4 - CRC (TTX-030 + Budigalimab)
  9. description
    Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG008
    title
    Cohort 6 - HNSCC (TTX-030 + Budigalimab)
  10. description
    Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG009
    title
    Cohort 8 - GEC (TTX-030 + Budigalimab)
  11. description
    Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG010
    title
    Cohort 10 - UCC (TTX-030 + Pembrolizumab)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        28
      7. group Id
        FG006
        num Subjects
        17
      8. group Id
        FG007
        num Subjects
        14
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        23
      11. group Id
        FG010
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        28
      7. group Id
        FG006
        num Subjects
        17
      8. group Id
        FG007
        num Subjects
        14
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        23
      11. group Id
        FG010
        num Subjects
        8
      type
      COMPLETED
    3. 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
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG000
    title
    Cohort 1 - Safety Lead-in (TTX-030 + Budigalimab + mFOLFOX6)
  2. description
    Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG001
    title
    Cohort 3B - Gastric (TTX-030 + Budigalimab + mFOLFOX6)
  3. description
    Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG002
    title
    Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
  4. description
    Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
    id
    FG003
    title
    Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
  5. description
    Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG004
    title
    Cohort 2 - mCRPC (TTX-030 + Budigalimab + Docetaxel)
  6. description
    Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    FG005
    title
    Cohort 9 - Pancreatic (TTX-030 + Budigalimab + Gemcitabine + Nab-Paclitaxel)
  7. description
    Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
    id
    FG006
    title
    Cohort 11 - Pancreatic (TTX-030 + Gemcitabine + Nab-Paclitaxel)
  8. description
    Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG007
    title
    Cohort 4 - CRC (TTX-030 + Budigalimab)
  9. description
    Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG008
    title
    Cohort 6 - HNSCC (TTX-030 + Budigalimab)
  10. description
    Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG009
    title
    Cohort 8 - GEC (TTX-030 + Budigalimab)
  11. description
    Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
    id
    FG010
    title
    Cohort 10 - UCC (TTX-030 + Pembrolizumab)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        28
      7. group Id
        FG006
        num Subjects
        17
      8. group Id
        FG007
        num Subjects
        14
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        23
      11. group Id
        FG010
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        28
      7. group Id
        FG006
        num Subjects
        17
      8. group Id
        FG007
        num Subjects
        14
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        23
      11. group Id
        FG010
        num Subjects
        8
      type
      COMPLETED
    3. 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
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice