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NCT04579757 · OUTCOME

Dose Escalation and Dose Expansion Phases: Serum Concentration of Tislelizumab

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.

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Preinfusion on Day 1 of Cycles 1, 2, 5, 9, 17; end of infusion on Day 1 of Cycles 1 and 5; on Days 8 and 15 of Cycle 1 (cycle duration: 3 weeks)

What was measured

Blood samples were collected at the specified timepoints to determine serum concentration of tislelizumab.

Analysis population: The PK analysis set included all patients with at least 1 quantifiable concentration of surufatinib or tislelizumab. Only patients with data collected at specified timepoints are reported.

Groups in this outcome

Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab

Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 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.

Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab

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.

Dose Expansion Phase: Cohort A: CRC

Patients with microsatellite stable, locally advanced or metastatic 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.

Dose Expansion Phase: Cohort B1: Thoracic NETs

Patients with thoracic 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.

Dose Expansion Phase: Cohort B2: GEP NETs

Patients with 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.

Dose Expansion Phase: Cohort C: SCLC

Patients with locally advanced or metastatic 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.

Dose Expansion Phase: Cohort D: GC

Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (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.

Dose Expansion Phase: Cohort E2: UPS

Patients with 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.

Dose Expansion Phase: Cohort F: ATC

Patients with locally advanced or metastatic ATC and who had a 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC15
Dose Expansion Phase: Cohort B1: Thoracic NETs10
Dose Expansion Phase: Cohort B2: GEP NETs19
Dose Expansion Phase: Cohort C: SCLC15
Dose Expansion Phase: Cohort D: GC3
Dose Expansion Phase: Cohort E2: UPS9
Dose Expansion Phase: Cohort F: ATC2

Reported measurements

Cycle 1 Day 1: Preinfusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC15
Dose Expansion Phase: Cohort B1: Thoracic NETs9
Dose Expansion Phase: Cohort B2: GEP NETs19
Dose Expansion Phase: Cohort C: SCLC15
Dose Expansion Phase: Cohort D: GC3
Dose Expansion Phase: Cohort E2: UPS9
Dose Expansion Phase: Cohort F: ATC2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + TislelizumabNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Escalation Phase: Surufatinib 300 mg + TislelizumabNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort A: CRCNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort B1: Thoracic NETsNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort B2: GEP NETsNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort C: SCLCNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort D: GCNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort E2: UPSNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Dose Expansion Phase: Cohort F: ATCNANANot reportedNot reportedNA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
Cycle 1 Day 1: End of Infusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC15
Dose Expansion Phase: Cohort B1: Thoracic NETs10
Dose Expansion Phase: Cohort B2: GEP NETs19
Dose Expansion Phase: Cohort C: SCLC15
Dose Expansion Phase: Cohort D: GC3
Dose Expansion Phase: Cohort E2: UPS9
Dose Expansion Phase: Cohort F: ATC2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab44550.07420.98Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab62750.017420.53Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC57233.38846.28Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs70990.041600.73Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs61136.815927.90Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC66220.017336.43Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC67966.745015.59Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS55955.615499.61Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC42200.012727.92Not reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC13
Dose Expansion Phase: Cohort B1: Thoracic NETs8
Dose Expansion Phase: Cohort B2: GEP NETs18
Dose Expansion Phase: Cohort C: SCLC12
Dose Expansion Phase: Cohort D: GC3
Dose Expansion Phase: Cohort E2: UPS8
Dose Expansion Phase: Cohort F: ATC2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab16980.06850.75Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab26216.77702.32Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC26446.26387.83Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs29575.05751.46Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs32244.47253.58Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC35450.08899.39Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC38233.335800.33Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS25475.06549.10Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC16050.01767.77Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC12
Dose Expansion Phase: Cohort B1: Thoracic NETs7
Dose Expansion Phase: Cohort B2: GEP NETs16
Dose Expansion Phase: Cohort C: SCLC12
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS8
Dose Expansion Phase: Cohort F: ATC2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab14296.75945.36Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab17900.05297.55Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC17414.24199.94Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs20571.42817.63Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs24506.36403.07Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC23783.34274.20Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC43950.040658.64Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS19300.04755.45Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC10940.02489.02Not reportedNot reportedNot reported
Cycle 2 Day 1: Preinfusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab5
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab5
Dose Expansion Phase: Cohort A: CRC14
Dose Expansion Phase: Cohort B1: Thoracic NETs6
Dose Expansion Phase: Cohort B2: GEP NETs15
Dose Expansion Phase: Cohort C: SCLC12
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS8
Dose Expansion Phase: Cohort F: ATC2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab9564.07871.14Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab13804.04782.16Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC13858.64730.49Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs14033.32436.12Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs18020.05688.23Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC17725.03860.55Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC38000.036910.97Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS12161.34443.93Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC7640.02729.43Not reportedNot reportedNot reported
Cycle 5 Day 1: Preinfusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab3
Dose Expansion Phase: Cohort A: CRC8
Dose Expansion Phase: Cohort B1: Thoracic NETs1
Dose Expansion Phase: Cohort B2: GEP NETs8
Dose Expansion Phase: Cohort C: SCLC4
Dose Expansion Phase: Cohort D: GC1
Dose Expansion Phase: Cohort E2: UPS3
Dose Expansion Phase: Cohort F: ATC1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab24400.014028.90Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC36412.534947.57Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs46400.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort B2: GEP NETs41575.010065.32Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC31225.012388.81Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC20100.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort E2: UPS19200.03143.25Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC22700.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Cycle 5 Day 1: End of Infusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab3
Dose Expansion Phase: Cohort A: CRC7
Dose Expansion Phase: Cohort B1: Thoracic NETs2
Dose Expansion Phase: Cohort B2: GEP NETs8
Dose Expansion Phase: Cohort C: SCLC4
Dose Expansion Phase: Cohort D: GC1
Dose Expansion Phase: Cohort E2: UPS3
Dose Expansion Phase: Cohort F: ATC1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab87166.734425.04Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC102500.026662.02Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs117500.06363.96Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs113475.016286.34Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC117550.043800.65Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC80800.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort E2: UPS103033.317737.06Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC69000.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Cycle 9 Day 1: Preinfusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab2
Dose Expansion Phase: Cohort A: CRC1
Dose Expansion Phase: Cohort B1: Thoracic NETs1
Dose Expansion Phase: Cohort B2: GEP NETs5
Dose Expansion Phase: Cohort C: SCLC2
Dose Expansion Phase: Cohort D: GC0
Dose Expansion Phase: Cohort E2: UPS2
Dose Expansion Phase: Cohort F: ATC0
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab22700.04101.22Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC44800.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort B1: Thoracic NETs50000.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort B2: GEP NETs45500.05384.24Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC41200.024607.32Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS41100.016970.56Not reportedNot reportedNot reported
Cycle 17 Day 1: Preinfusion

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab0
Dose Expansion Phase: Cohort A: CRC0
Dose Expansion Phase: Cohort B1: Thoracic NETs1
Dose Expansion Phase: Cohort B2: GEP NETs3
Dose Expansion Phase: Cohort C: SCLC1
Dose Expansion Phase: Cohort D: GC0
Dose Expansion Phase: Cohort E2: UPS1
Dose Expansion Phase: Cohort F: ATC0
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort B1: Thoracic NETs41300.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort B2: GEP NETs44766.712196.86Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC51900.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort E2: UPS47300.0NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG003
        spread
        NA
        value
        NA
      5. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG004
        spread
        NA
        value
        NA
      6. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG005
        spread
        NA
        value
        NA
      7. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG006
        spread
        NA
        value
        NA
      8. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG007
        spread
        NA
        value
        NA
      9. comment
        NA indicates that mean and SD were not estimable as the values were below the LLOQ of 400 ng/mL.
        group Id
        OG008
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        19
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        9
      9. group Id
        OG008
        value
        2
      units
      Participants
    title
    Cycle 1 Day 1: Preinfusion
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7420.98
        value
        44550.0
      2. group Id
        OG001
        spread
        17420.53
        value
        62750.0
      3. group Id
        OG002
        spread
        8846.28
        value
        57233.3
      4. group Id
        OG003
        spread
        41600.73
        value
        70990.0
      5. group Id
        OG004
        spread
        15927.90
        value
        61136.8
      6. group Id
        OG005
        spread
        17336.43
        value
        66220.0
      7. group Id
        OG006
        spread
        45015.59
        value
        67966.7
      8. group Id
        OG007
        spread
        15499.61
        value
        55955.6
      9. group Id
        OG008
        spread
        12727.92
        value
        42200.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        19
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        9
      9. group Id
        OG008
        value
        2
      units
      Participants
    title
    Cycle 1 Day 1: End of Infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6850.75
        value
        16980.0
      2. group Id
        OG001
        spread
        7702.32
        value
        26216.7
      3. group Id
        OG002
        spread
        6387.83
        value
        26446.2
      4. group Id
        OG003
        spread
        5751.46
        value
        29575.0
      5. group Id
        OG004
        spread
        7253.58
        value
        32244.4
      6. group Id
        OG005
        spread
        8899.39
        value
        35450.0
      7. group Id
        OG006
        spread
        35800.33
        value
        38233.3
      8. group Id
        OG007
        spread
        6549.10
        value
        25475.0
      9. group Id
        OG008
        spread
        1767.77
        value
        16050.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        18
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        8
      9. group Id
        OG008
        value
        2
      units
      Participants
    title
    Cycle 1 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5945.36
        value
        14296.7
      2. group Id
        OG001
        spread
        5297.55
        value
        17900.0
      3. group Id
        OG002
        spread
        4199.94
        value
        17414.2
      4. group Id
        OG003
        spread
        2817.63
        value
        20571.4
      5. group Id
        OG004
        spread
        6403.07
        value
        24506.3
      6. group Id
        OG005
        spread
        4274.20
        value
        23783.3
      7. group Id
        OG006
        spread
        40658.64
        value
        43950.0
      8. group Id
        OG007
        spread
        4755.45
        value
        19300.0
      9. group Id
        OG008
        spread
        2489.02
        value
        10940.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        16
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        8
      9. group Id
        OG008
        value
        2
      units
      Participants
    title
    Cycle 1 Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        7871.14
        value
        9564.0
      2. group Id
        OG001
        spread
        4782.16
        value
        13804.0
      3. group Id
        OG002
        spread
        4730.49
        value
        13858.6
      4. group Id
        OG003
        spread
        2436.12
        value
        14033.3
      5. group Id
        OG004
        spread
        5688.23
        value
        18020.0
      6. group Id
        OG005
        spread
        3860.55
        value
        17725.0
      7. group Id
        OG006
        spread
        36910.97
        value
        38000.0
      8. group Id
        OG007
        spread
        4443.93
        value
        12161.3
      9. group Id
        OG008
        spread
        2729.43
        value
        7640.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        8
      9. group Id
        OG008
        value
        2
      units
      Participants
    title
    Cycle 2 Day 1: Preinfusion
  6. categories
    1. measurements
      1. group Id
        OG001
        spread
        14028.90
        value
        24400.0
      2. group Id
        OG002
        spread
        34947.57
        value
        36412.5
      3. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG003
        spread
        NA
        value
        46400.0
      4. group Id
        OG004
        spread
        10065.32
        value
        41575.0
      5. group Id
        OG005
        spread
        12388.81
        value
        31225.0
      6. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG006
        spread
        NA
        value
        20100.0
      7. group Id
        OG007
        spread
        3143.25
        value
        19200.0
      8. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG008
        spread
        NA
        value
        22700.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        1
      units
      Participants
    title
    Cycle 5 Day 1: Preinfusion
  7. categories
    1. measurements
      1. group Id
        OG001
        spread
        34425.04
        value
        87166.7
      2. group Id
        OG002
        spread
        26662.02
        value
        102500.0
      3. group Id
        OG003
        spread
        6363.96
        value
        117500.0
      4. group Id
        OG004
        spread
        16286.34
        value
        113475.0
      5. group Id
        OG005
        spread
        43800.65
        value
        117550.0
      6. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG006
        spread
        NA
        value
        80800.0
      7. group Id
        OG007
        spread
        17737.06
        value
        103033.3
      8. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG008
        spread
        NA
        value
        69000.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        1
      units
      Participants
    title
    Cycle 5 Day 1: End of Infusion
  8. categories
    1. measurements
      1. group Id
        OG001
        spread
        4101.22
        value
        22700.0
      2. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG002
        spread
        NA
        value
        44800.0
      3. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG003
        spread
        NA
        value
        50000.0
      4. group Id
        OG004
        spread
        5384.24
        value
        45500.0
      5. group Id
        OG005
        spread
        24607.32
        value
        41200.0
      6. group Id
        OG007
        spread
        16970.56
        value
        41100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 9 Day 1: Preinfusion
  9. categories
    1. measurements
      1. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG003
        spread
        NA
        value
        41300.0
      2. group Id
        OG004
        spread
        12196.86
        value
        44766.7
      3. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG005
        spread
        NA
        value
        51900.0
      4. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG007
        spread
        NA
        value
        47300.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 17 Day 1: Preinfusion
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      19
    6. group Id
      OG005
      value
      15
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      9
    9. group Id
      OG008
      value
      2
    units
    Participants
description
Blood samples were collected at the specified timepoints to determine serum concentration of tislelizumab.
dispersion Type
Standard Deviation
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 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
    OG000
    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
    OG001
    title
    Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
  3. description
    Patients with microsatellite stable, locally advanced or metastatic 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
    OG002
    title
    Dose Expansion Phase: Cohort A: CRC
  4. description
    Patients with thoracic 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
    OG003
    title
    Dose Expansion Phase: Cohort B1: Thoracic NETs
  5. description
    Patients with 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
    OG004
    title
    Dose Expansion Phase: Cohort B2: GEP NETs
  6. description
    Patients with locally advanced or metastatic 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
    OG005
    title
    Dose Expansion Phase: Cohort C: SCLC
  7. description
    Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (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
    OG006
    title
    Dose Expansion Phase: Cohort D: GC
  8. description
    Patients with 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
    OG007
    title
    Dose Expansion Phase: Cohort E2: UPS
  9. description
    Patients with locally advanced or metastatic ATC and who had a 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
    OG008
    title
    Dose Expansion Phase: Cohort F: ATC
param Type
MEAN
population Description
The PK analysis set included all patients with at least 1 quantifiable concentration of surufatinib or tislelizumab. Only patients with data collected at specified timepoints are reported.
reporting Status
POSTED
time Frame
Preinfusion on Day 1 of Cycles 1, 2, 5, 9, 17; end of infusion on Day 1 of Cycles 1 and 5; on Days 8 and 15 of Cycle 1 (cycle duration: 3 weeks)
title
Dose Escalation and Dose Expansion Phases: Serum Concentration of Tislelizumab
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice