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NCT04579757 · FLOW

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Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors · Source last updated 2025-05-08

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

groups
  1. description
    Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 milligrams (mg) orally once daily (QD) in combination with tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) until progressive disease (PD), unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG000
    title
    Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
  2. description
    Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG001
    title
    Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
  3. description
    Patients with microsatellite stable, locally advanced or metastatic colorectal cancer (CRC) that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG002
    title
    Dose Expansion Phase: Cohort A: CRC
  4. description
    Patients with thoracic neuroendocrine tumor (NET) who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG003
    title
    Dose Expansion Phase: Cohort B1: Thoracic NETs
  5. description
    Patients with gastroenteropancreatic (GEP) NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG004
    title
    Dose Expansion Phase: Cohort B2: GEP NETs
  6. description
    Patients with locally advanced or metastatic small-cell lung cancer (SCLC) that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG005
    title
    Dose Expansion Phase: Cohort C: SCLC
  7. description
    Patients with microsatellite stable, programmed death-ligand 1 (PD-L1) ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (gastric cancer \[GC\]), and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG006
    title
    Dose Expansion Phase: Cohort D: GC
  8. description
    Patients with undifferentiated pleomorphic sarcoma (UPS) who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG007
    title
    Dose Expansion Phase: Cohort E2: UPS
  9. description
    Patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) and who had a B-Raf kinase V600E (BRAFV600E) mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG008
    title
    Dose Expansion Phase: Cohort F: ATC
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
        0
      4. group Id
        FG003
        num Subjects
        2
      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
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      type
      Death
    3. 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
        2
      5. group Id
        FG004
        num Subjects
        1
      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
        0
      type
      Physician Decision
    4. 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
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      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
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      type
      Radiological or Clinical PD
    7. 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
        2
      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
      type
      Start of New Therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        3
      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
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        19
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of a dose-escalation phase and a dose-expansion phase. A total of 12 patients in dose-escalation phase and 75 patients in dose-expansion phase were enrolled in this study. The study was terminated early based on the strategic re-evaluation of clinical development of surufatinib in the United States and Europe with no safety concerns. No patients were enrolled in Cohort E1 (alveolar soft part sarcoma) in the dose-expansion phase, hence this cohort is not presented in results.
recruitment Details
This phase 1b/2, 2-part, open-label study was conducted in patients with advanced solid tumors.
Complete source fields
groups
  1. description
    Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 milligrams (mg) orally once daily (QD) in combination with tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) until progressive disease (PD), unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG000
    title
    Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
  2. description
    Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG001
    title
    Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
  3. description
    Patients with microsatellite stable, locally advanced or metastatic colorectal cancer (CRC) that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG002
    title
    Dose Expansion Phase: Cohort A: CRC
  4. description
    Patients with thoracic neuroendocrine tumor (NET) who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG003
    title
    Dose Expansion Phase: Cohort B1: Thoracic NETs
  5. description
    Patients with gastroenteropancreatic (GEP) NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG004
    title
    Dose Expansion Phase: Cohort B2: GEP NETs
  6. description
    Patients with locally advanced or metastatic small-cell lung cancer (SCLC) that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG005
    title
    Dose Expansion Phase: Cohort C: SCLC
  7. description
    Patients with microsatellite stable, programmed death-ligand 1 (PD-L1) ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (gastric cancer \[GC\]), and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG006
    title
    Dose Expansion Phase: Cohort D: GC
  8. description
    Patients with undifferentiated pleomorphic sarcoma (UPS) who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG007
    title
    Dose Expansion Phase: Cohort E2: UPS
  9. description
    Patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) and who had a B-Raf kinase V600E (BRAFV600E) mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    FG008
    title
    Dose Expansion Phase: Cohort F: ATC
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
        0
      4. group Id
        FG003
        num Subjects
        2
      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
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      type
      Death
    3. 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
        2
      5. group Id
        FG004
        num Subjects
        1
      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
        0
      type
      Physician Decision
    4. 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
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      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
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      type
      Radiological or Clinical PD
    7. 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
        2
      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
      type
      Start of New Therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        3
      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
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        19
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of a dose-escalation phase and a dose-expansion phase. A total of 12 patients in dose-escalation phase and 75 patients in dose-expansion phase were enrolled in this study. The study was terminated early based on the strategic re-evaluation of clinical development of surufatinib in the United States and Europe with no safety concerns. No patients were enrolled in Cohort E1 (alveolar soft part sarcoma) in the dose-expansion phase, hence this cohort is not presented in results.
recruitment Details
This phase 1b/2, 2-part, open-label study was conducted in patients with advanced solid tumors.

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Preserved source evidence · Not medical advice