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NCT05091528 · FLOW

Participant flow

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers · Source last updated 2022-08-18

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

groups
  1. description
    SBT6050 plus trastuzumab deruxtecan SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
    id
    FG000
    title
    SBT6050 + T-DXd (5.4 mg/kg)
  2. description
    SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
    id
    FG001
    title
    SBT6050 + T-DXd (6.4 mg/kg)
  3. description
    SBT6050 plus tucatinib, trastuzumab, and capecitabine SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles capecitabine: 1000 mg/m2 PO BID for 14 days of each 21-day cycle
    id
    FG002
    title
    SBT6050 + Tucatinib + Trastuzumab + Capecitabine
  4. description
    SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
    id
    FG003
    title
    SBT6050 + Tucatinib + Trastuzumab
periods
  1. drop Withdraws
    1. 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
        1
      type
      Study Termination by Sponsor
    milestones
    1. 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
      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
      type
      COMPLETED
    3. 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
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    SBT6050 plus trastuzumab deruxtecan SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
    id
    FG000
    title
    SBT6050 + T-DXd (5.4 mg/kg)
  2. description
    SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
    id
    FG001
    title
    SBT6050 + T-DXd (6.4 mg/kg)
  3. description
    SBT6050 plus tucatinib, trastuzumab, and capecitabine SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles capecitabine: 1000 mg/m2 PO BID for 14 days of each 21-day cycle
    id
    FG002
    title
    SBT6050 + Tucatinib + Trastuzumab + Capecitabine
  4. description
    SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
    id
    FG003
    title
    SBT6050 + Tucatinib + Trastuzumab
periods
  1. drop Withdraws
    1. 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
        1
      type
      Study Termination by Sponsor
    milestones
    1. 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
      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
      type
      COMPLETED
    3. 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
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice