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
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 6 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 15 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 10 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 19 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 15 |
|---|
| Dose Expansion Phase: Cohort D: GC | 3 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 9 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 2 |
|---|
Reported measurements
Cycle 1 Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 5 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 15 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 10 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 19 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 15 |
|---|
| Dose Expansion Phase: Cohort D: GC | 3 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 9 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 2 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort A: CRC | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort C: SCLC | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort D: GC | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort E2: UPS | NA | NA | Not reported | Not reported | 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. |
|---|
| Dose Expansion Phase: Cohort F: ATC | NA | NA | Not reported | Not reported | 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. |
|---|
Cycle 1 Day 1: 2 to 4 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 6 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 15 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 10 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 19 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 15 |
|---|
| Dose Expansion Phase: Cohort D: GC | 3 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 9 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 2 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 293.03 | 244.593 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 576.00 | 415.108 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort A: CRC | 426.62 | 312.209 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 276.36 | 243.080 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 294.13 | 292.335 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 406.97 | 212.791 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort D: GC | 506.27 | 653.616 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 275.64 | 165.937 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort F: ATC | 782.50 | 463.155 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 8: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 4 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 12 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 5 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 14 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 9 |
|---|
| Dose Expansion Phase: Cohort D: GC | 2 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 6 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 1 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 77.00 | 44.023 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 189.93 | 113.750 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort A: CRC | 170.33 | 131.533 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 100.12 | 71.600 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 92.26 | 63.901 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 122.80 | 70.875 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort D: GC | 109.10 | 18.243 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 97.70 | 40.471 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort F: ATC | 709.00 | NA | Not reported | Not reported | NA indicates that SD was not estimable for 1 patient. |
|---|
Cycle 1 Day 15: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 5 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 5 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 11 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 4 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 15 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 10 |
|---|
| Dose Expansion Phase: Cohort D: GC | 2 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 6 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 0 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 64.36 | 15.246 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 181.56 | 125.156 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort A: CRC | 135.96 | 83.673 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 159.00 | 139.802 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 84.95 | 70.121 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 96.79 | 43.933 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort D: GC | 111.05 | 19.728 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 118.92 | 75.457 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 15: 2 to 4 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 3 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 3 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 13 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 4 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 12 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 11 |
|---|
| Dose Expansion Phase: Cohort D: GC | 2 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 7 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 0 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 318.67 | 146.770 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 757.33 | 498.399 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort A: CRC | 657.54 | 369.146 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 354.25 | 52.519 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 471.78 | 330.598 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 425.75 | 235.698 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort D: GC | 188.00 | 41.012 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 518.00 | 302.182 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 5 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 4 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 10 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 3 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 9 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 11 |
|---|
| Dose Expansion Phase: Cohort D: GC | 2 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 2 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 1 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 45.82 | 27.567 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 96.80 | 38.895 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort A: CRC | 151.44 | 99.521 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 89.37 | 53.475 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 75.94 | 53.028 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 117.68 | 79.721 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort D: GC | 146.50 | 26.163 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 71.95 | 9.405 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort F: ATC | 147.00 | NA | Not reported | Not reported | NA indicates that SD was not estimable for 1 patient. |
|---|
Cycle 5 Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 0 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 2 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 3 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 1 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 4 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 2 |
|---|
| Dose Expansion Phase: Cohort D: GC | 0 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 0 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 0 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 55.25 | 8.132 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort A: CRC | 141.20 | 117.885 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 41.00 | NA | Not reported | Not reported | NA indicates that SD was not estimable for 1 patient. |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 61.08 | 22.279 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 105.70 | 54.164 | Not reported | Not reported | Not reported |
|---|
Cycle 9 Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 0 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 1 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 0 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 0 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 3 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 1 |
|---|
| Dose Expansion Phase: Cohort D: GC | 0 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 0 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 0 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 65.90 | NA | Not reported | Not reported | NA indicates that SD was not estimable for 1 patient. |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 87.20 | 14.964 | Not reported | Not reported | Not reported |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 41.70 | NA | Not reported | Not reported | NA indicates that SD was not estimable for 1 patient. |
|---|
Cycle 17 Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 0 |
|---|
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 0 |
|---|
| Dose Expansion Phase: Cohort A: CRC | 0 |
|---|
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 0 |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 1 |
|---|
| Dose Expansion Phase: Cohort C: SCLC | 0 |
|---|
| Dose Expansion Phase: Cohort D: GC | 0 |
|---|
| Dose Expansion Phase: Cohort E2: UPS | 0 |
|---|
| Dose Expansion Phase: Cohort F: ATC | 0 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Expansion Phase: Cohort B2: GEP NETs | 85.10 | NA | Not reported | Not reported | NA indicates that SD was not estimable for 1 patient. |
|---|
Complete source fields
- classes
- categories
- measurements
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 244.593
- value
- 293.03
- group Id
- OG001
- spread
- 415.108
- value
- 576.00
- group Id
- OG002
- spread
- 312.209
- value
- 426.62
- group Id
- OG003
- spread
- 243.080
- value
- 276.36
- group Id
- OG004
- spread
- 292.335
- value
- 294.13
- group Id
- OG005
- spread
- 212.791
- value
- 406.97
- group Id
- OG006
- spread
- 653.616
- value
- 506.27
- group Id
- OG007
- spread
- 165.937
- value
- 275.64
- group Id
- OG008
- spread
- 463.155
- value
- 782.50
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1: 2 to 4 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 44.023
- value
- 77.00
- group Id
- OG001
- spread
- 113.750
- value
- 189.93
- group Id
- OG002
- spread
- 131.533
- value
- 170.33
- group Id
- OG003
- spread
- 71.600
- value
- 100.12
- group Id
- OG004
- spread
- 63.901
- value
- 92.26
- group Id
- OG005
- spread
- 70.875
- value
- 122.80
- group Id
- OG006
- spread
- 18.243
- value
- 109.10
- group Id
- OG007
- spread
- 40.471
- value
- 97.70
- comment
- NA indicates that SD was not estimable for 1 patient.
- group Id
- OG008
- spread
- NA
- value
- 709.00
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 8: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 15.246
- value
- 64.36
- group Id
- OG001
- spread
- 125.156
- value
- 181.56
- group Id
- OG002
- spread
- 83.673
- value
- 135.96
- group Id
- OG003
- spread
- 139.802
- value
- 159.00
- group Id
- OG004
- spread
- 70.121
- value
- 84.95
- group Id
- OG005
- spread
- 43.933
- value
- 96.79
- group Id
- OG006
- spread
- 19.728
- value
- 111.05
- group Id
- OG007
- spread
- 75.457
- value
- 118.92
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 146.770
- value
- 318.67
- group Id
- OG001
- spread
- 498.399
- value
- 757.33
- group Id
- OG002
- spread
- 369.146
- value
- 657.54
- group Id
- OG003
- spread
- 52.519
- value
- 354.25
- group Id
- OG004
- spread
- 330.598
- value
- 471.78
- group Id
- OG005
- spread
- 235.698
- value
- 425.75
- group Id
- OG006
- spread
- 41.012
- value
- 188.00
- group Id
- OG007
- spread
- 302.182
- value
- 518.00
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15: 2 to 4 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 27.567
- value
- 45.82
- group Id
- OG001
- spread
- 38.895
- value
- 96.80
- group Id
- OG002
- spread
- 99.521
- value
- 151.44
- group Id
- OG003
- spread
- 53.475
- value
- 89.37
- group Id
- OG004
- spread
- 53.028
- value
- 75.94
- group Id
- OG005
- spread
- 79.721
- value
- 117.68
- group Id
- OG006
- spread
- 26.163
- value
- 146.50
- group Id
- OG007
- spread
- 9.405
- value
- 71.95
- comment
- NA indicates that SD was not estimable for 1 patient.
- group Id
- OG008
- spread
- NA
- value
- 147.00
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- units
- Participants
- title
- Cycle 2 Day 1: Pre-dose
- categories
- measurements
- group Id
- OG001
- spread
- 8.132
- value
- 55.25
- group Id
- OG002
- spread
- 117.885
- value
- 141.20
- comment
- NA indicates that SD was not estimable for 1 patient.
- group Id
- OG003
- spread
- NA
- value
- 41.00
- group Id
- OG004
- spread
- 22.279
- value
- 61.08
- group Id
- OG005
- spread
- 54.164
- value
- 105.70
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 5 Day 1: Pre-dose
- categories
- measurements
- comment
- NA indicates that SD was not estimable for 1 patient.
- group Id
- OG001
- spread
- NA
- value
- 65.90
- group Id
- OG004
- spread
- 14.964
- value
- 87.20
- comment
- NA indicates that SD was not estimable for 1 patient.
- group Id
- OG005
- spread
- NA
- value
- 41.70
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 9 Day 1: Pre-dose
- categories
- measurements
- comment
- NA indicates that SD was not estimable for 1 patient.
- group Id
- OG004
- spread
- NA
- value
- 85.10
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 17 Day 1: Pre-dose
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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