{"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.","groupId":"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.","groupId":"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.","groupId":"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.","groupId":"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.","groupId":"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.","groupId":"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.","groupId":"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.","groupId":"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.","groupId":"OG008","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"9"},{"groupId":"OG008","value":"2"}],"units":"Participants"}],"title":"Cycle 1 Day 1: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"244.593","value":"293.03"},{"groupId":"OG001","spread":"415.108","value":"576.00"},{"groupId":"OG002","spread":"312.209","value":"426.62"},{"groupId":"OG003","spread":"243.080","value":"276.36"},{"groupId":"OG004","spread":"292.335","value":"294.13"},{"groupId":"OG005","spread":"212.791","value":"406.97"},{"groupId":"OG006","spread":"653.616","value":"506.27"},{"groupId":"OG007","spread":"165.937","value":"275.64"},{"groupId":"OG008","spread":"463.155","value":"782.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"9"},{"groupId":"OG008","value":"2"}],"units":"Participants"}],"title":"Cycle 1 Day 1: 2 to 4 hours post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"44.023","value":"77.00"},{"groupId":"OG001","spread":"113.750","value":"189.93"},{"groupId":"OG002","spread":"131.533","value":"170.33"},{"groupId":"OG003","spread":"71.600","value":"100.12"},{"groupId":"OG004","spread":"63.901","value":"92.26"},{"groupId":"OG005","spread":"70.875","value":"122.80"},{"groupId":"OG006","spread":"18.243","value":"109.10"},{"groupId":"OG007","spread":"40.471","value":"97.70"},{"comment":"NA indicates that SD was not estimable for 1 patient.","groupId":"OG008","spread":"NA","value":"709.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"14"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"6"},{"groupId":"OG008","value":"1"}],"units":"Participants"}],"title":"Cycle 1 Day 8: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.246","value":"64.36"},{"groupId":"OG001","spread":"125.156","value":"181.56"},{"groupId":"OG002","spread":"83.673","value":"135.96"},{"groupId":"OG003","spread":"139.802","value":"159.00"},{"groupId":"OG004","spread":"70.121","value":"84.95"},{"groupId":"OG005","spread":"43.933","value":"96.79"},{"groupId":"OG006","spread":"19.728","value":"111.05"},{"groupId":"OG007","spread":"75.457","value":"118.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"15"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"6"},{"groupId":"OG008","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"146.770","value":"318.67"},{"groupId":"OG001","spread":"498.399","value":"757.33"},{"groupId":"OG002","spread":"369.146","value":"657.54"},{"groupId":"OG003","spread":"52.519","value":"354.25"},{"groupId":"OG004","spread":"330.598","value":"471.78"},{"groupId":"OG005","spread":"235.698","value":"425.75"},{"groupId":"OG006","spread":"41.012","value":"188.00"},{"groupId":"OG007","spread":"302.182","value":"518.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"12"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15: 2 to 4 hours post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.567","value":"45.82"},{"groupId":"OG001","spread":"38.895","value":"96.80"},{"groupId":"OG002","spread":"99.521","value":"151.44"},{"groupId":"OG003","spread":"53.475","value":"89.37"},{"groupId":"OG004","spread":"53.028","value":"75.94"},{"groupId":"OG005","spread":"79.721","value":"117.68"},{"groupId":"OG006","spread":"26.163","value":"146.50"},{"groupId":"OG007","spread":"9.405","value":"71.95"},{"comment":"NA indicates that SD was not estimable for 1 patient.","groupId":"OG008","spread":"NA","value":"147.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"}],"units":"Participants"}],"title":"Cycle 2 Day 1: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"8.132","value":"55.25"},{"groupId":"OG002","spread":"117.885","value":"141.20"},{"comment":"NA indicates that SD was not estimable for 1 patient.","groupId":"OG003","spread":"NA","value":"41.00"},{"groupId":"OG004","spread":"22.279","value":"61.08"},{"groupId":"OG005","spread":"54.164","value":"105.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"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.","groupId":"OG001","spread":"NA","value":"65.90"},{"groupId":"OG004","spread":"14.964","value":"87.20"},{"comment":"NA indicates that SD was not estimable for 1 patient.","groupId":"OG005","spread":"NA","value":"41.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"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.","groupId":"OG004","spread":"NA","value":"85.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}],"units":"Participants"}],"title":"Cycle 17 Day 1: Pre-dose"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"9"},{"groupId":"OG008","value":"2"}],"units":"Participants"}],"description":"Blood samples were collected at the specified timepoints to determine plasma concentration of surufatinib.","dispersionType":"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"}],"paramType":"MEAN","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"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","unitOfMeasure":"nanograms per milliliter (ng/mL)"}