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NCT04579757 · OUTCOME

Dose Escalation and Dose Expansion Phases: Plasma Concentration of Surufatinib

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
nanograms per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose on Day 1 of Cycles 1, 2, 5, 9, 17 and on Days 8 and 15 of Cycle 1; 2 to 4 hours post-dose on Days 1 and 15 of Cycle 1 (cycle duration: 3 weeks)

What was measured

Blood samples were collected at the specified timepoints to determine plasma concentration of surufatinib.

Analysis population: The pharmacokinetic (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: Pre-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab5
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 nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + TislelizumabNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Escalation Phase: Surufatinib 300 mg + TislelizumabNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort A: CRCNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort B1: Thoracic NETsNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort B2: GEP NETsNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort C: SCLCNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort D: GCNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort E2: UPSNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Dose Expansion Phase: Cohort F: ATCNANANot reportedNot reportedNA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
Cycle 1 Day 1: 2 to 4 hours post-dose

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 nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab293.03244.593Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab576.00415.108Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC426.62312.209Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs276.36243.080Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs294.13292.335Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC406.97212.791Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC506.27653.616Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS275.64165.937Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC782.50463.155Not reportedNot reportedNot reported
Cycle 1 Day 8: Pre-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab4
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC12
Dose Expansion Phase: Cohort B1: Thoracic NETs5
Dose Expansion Phase: Cohort B2: GEP NETs14
Dose Expansion Phase: Cohort C: SCLC9
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS6
Dose Expansion Phase: Cohort F: ATC1
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab77.0044.023Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab189.93113.750Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC170.33131.533Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs100.1271.600Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs92.2663.901Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC122.8070.875Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC109.1018.243Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS97.7040.471Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC709.00NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Cycle 1 Day 15: Pre-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab5
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab5
Dose Expansion Phase: Cohort A: CRC11
Dose Expansion Phase: Cohort B1: Thoracic NETs4
Dose Expansion Phase: Cohort B2: GEP NETs15
Dose Expansion Phase: Cohort C: SCLC10
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS6
Dose Expansion Phase: Cohort F: ATC0
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab64.3615.246Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab181.56125.156Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC135.9683.673Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs159.00139.802Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs84.9570.121Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC96.7943.933Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC111.0519.728Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS118.9275.457Not reportedNot reportedNot reported
Cycle 1 Day 15: 2 to 4 hours post-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab3
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab3
Dose Expansion Phase: Cohort A: CRC13
Dose Expansion Phase: Cohort B1: Thoracic NETs4
Dose Expansion Phase: Cohort B2: GEP NETs12
Dose Expansion Phase: Cohort C: SCLC11
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS7
Dose Expansion Phase: Cohort F: ATC0
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab318.67146.770Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab757.33498.399Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC657.54369.146Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs354.2552.519Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs471.78330.598Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC425.75235.698Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC188.0041.012Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS518.00302.182Not reportedNot reportedNot reported
Cycle 2 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab5
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab4
Dose Expansion Phase: Cohort A: CRC10
Dose Expansion Phase: Cohort B1: Thoracic NETs3
Dose Expansion Phase: Cohort B2: GEP NETs9
Dose Expansion Phase: Cohort C: SCLC11
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS2
Dose Expansion Phase: Cohort F: ATC1
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab45.8227.567Not reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab96.8038.895Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC151.4499.521Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs89.3753.475Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs75.9453.028Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC117.6879.721Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC146.5026.163Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS71.959.405Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC147.00NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Cycle 5 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab2
Dose Expansion Phase: Cohort A: CRC3
Dose Expansion Phase: Cohort B1: Thoracic NETs1
Dose Expansion Phase: Cohort B2: GEP NETs4
Dose Expansion Phase: Cohort C: SCLC2
Dose Expansion Phase: Cohort D: GC0
Dose Expansion Phase: Cohort E2: UPS0
Dose Expansion Phase: Cohort F: ATC0
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab55.258.132Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC141.20117.885Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs41.00NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort B2: GEP NETs61.0822.279Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC105.7054.164Not reportedNot reportedNot reported
Cycle 9 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab1
Dose Expansion Phase: Cohort A: CRC0
Dose Expansion Phase: Cohort B1: Thoracic NETs0
Dose Expansion Phase: Cohort B2: GEP NETs3
Dose Expansion Phase: Cohort C: SCLC1
Dose Expansion Phase: Cohort D: GC0
Dose Expansion Phase: Cohort E2: UPS0
Dose Expansion Phase: Cohort F: ATC0
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab65.90NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Dose Expansion Phase: Cohort B2: GEP NETs87.2014.964Not reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC41.70NANot reportedNot reportedNA indicates that SD was not estimable for 1 patient.
Cycle 17 Day 1: Pre-dose

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 NETs0
Dose Expansion Phase: Cohort B2: GEP NETs1
Dose Expansion Phase: Cohort C: SCLC0
Dose Expansion Phase: Cohort D: GC0
Dose Expansion Phase: Cohort E2: UPS0
Dose Expansion Phase: Cohort F: ATC0
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort B2: GEP NETs85.10NANot 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 standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG003
        spread
        NA
        value
        NA
      5. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG004
        spread
        NA
        value
        NA
      6. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG005
        spread
        NA
        value
        NA
      7. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG006
        spread
        NA
        value
        NA
      8. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG007
        spread
        NA
        value
        NA
      9. comment
        NA indicates that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ) of 1.00 ng/mL.
        group Id
        OG008
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      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: Pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        244.593
        value
        293.03
      2. group Id
        OG001
        spread
        415.108
        value
        576.00
      3. group Id
        OG002
        spread
        312.209
        value
        426.62
      4. group Id
        OG003
        spread
        243.080
        value
        276.36
      5. group Id
        OG004
        spread
        292.335
        value
        294.13
      6. group Id
        OG005
        spread
        212.791
        value
        406.97
      7. group Id
        OG006
        spread
        653.616
        value
        506.27
      8. group Id
        OG007
        spread
        165.937
        value
        275.64
      9. group Id
        OG008
        spread
        463.155
        value
        782.50
    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: 2 to 4 hours post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.023
        value
        77.00
      2. group Id
        OG001
        spread
        113.750
        value
        189.93
      3. group Id
        OG002
        spread
        131.533
        value
        170.33
      4. group Id
        OG003
        spread
        71.600
        value
        100.12
      5. group Id
        OG004
        spread
        63.901
        value
        92.26
      6. group Id
        OG005
        spread
        70.875
        value
        122.80
      7. group Id
        OG006
        spread
        18.243
        value
        109.10
      8. group Id
        OG007
        spread
        40.471
        value
        97.70
      9. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG008
        spread
        NA
        value
        709.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        14
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        6
      9. group Id
        OG008
        value
        1
      units
      Participants
    title
    Cycle 1 Day 8: Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.246
        value
        64.36
      2. group Id
        OG001
        spread
        125.156
        value
        181.56
      3. group Id
        OG002
        spread
        83.673
        value
        135.96
      4. group Id
        OG003
        spread
        139.802
        value
        159.00
      5. group Id
        OG004
        spread
        70.121
        value
        84.95
      6. group Id
        OG005
        spread
        43.933
        value
        96.79
      7. group Id
        OG006
        spread
        19.728
        value
        111.05
      8. group Id
        OG007
        spread
        75.457
        value
        118.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        6
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15: Pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        146.770
        value
        318.67
      2. group Id
        OG001
        spread
        498.399
        value
        757.33
      3. group Id
        OG002
        spread
        369.146
        value
        657.54
      4. group Id
        OG003
        spread
        52.519
        value
        354.25
      5. group Id
        OG004
        spread
        330.598
        value
        471.78
      6. group Id
        OG005
        spread
        235.698
        value
        425.75
      7. group Id
        OG006
        spread
        41.012
        value
        188.00
      8. group Id
        OG007
        spread
        302.182
        value
        518.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        11
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        7
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15: 2 to 4 hours post-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.567
        value
        45.82
      2. group Id
        OG001
        spread
        38.895
        value
        96.80
      3. group Id
        OG002
        spread
        99.521
        value
        151.44
      4. group Id
        OG003
        spread
        53.475
        value
        89.37
      5. group Id
        OG004
        spread
        53.028
        value
        75.94
      6. group Id
        OG005
        spread
        79.721
        value
        117.68
      7. group Id
        OG006
        spread
        26.163
        value
        146.50
      8. group Id
        OG007
        spread
        9.405
        value
        71.95
      9. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG008
        spread
        NA
        value
        147.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        11
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        1
      units
      Participants
    title
    Cycle 2 Day 1: Pre-dose
  7. categories
    1. measurements
      1. group Id
        OG001
        spread
        8.132
        value
        55.25
      2. group Id
        OG002
        spread
        117.885
        value
        141.20
      3. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG003
        spread
        NA
        value
        41.00
      4. group Id
        OG004
        spread
        22.279
        value
        61.08
      5. group Id
        OG005
        spread
        54.164
        value
        105.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 5 Day 1: Pre-dose
  8. categories
    1. measurements
      1. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG001
        spread
        NA
        value
        65.90
      2. group Id
        OG004
        spread
        14.964
        value
        87.20
      3. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG005
        spread
        NA
        value
        41.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 9 Day 1: Pre-dose
  9. categories
    1. measurements
      1. comment
        NA indicates that SD was not estimable for 1 patient.
        group Id
        OG004
        spread
        NA
        value
        85.10
    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
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      units
      Participants
    title
    Cycle 17 Day 1: Pre-dose
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 plasma concentration of surufatinib.
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 pharmacokinetic (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
Pre-dose on Day 1 of Cycles 1, 2, 5, 9, 17 and on Days 8 and 15 of Cycle 1; 2 to 4 hours post-dose on Days 1 and 15 of Cycle 1 (cycle duration: 3 weeks)
title
Dose Escalation and Dose Expansion Phases: Plasma Concentration of Surufatinib
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice