Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Surufatinib with Nab-paclitaxel, and Gemcitabine
Surufatinib · 12 trials · 10 indications
the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).
Progression-free survival(PFS) assessed by the investigator as per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
The AEs of the first 6 patients were evaluated by the possibly occurs Dose Limited Toxicity (DLT).
The incidence of confirmed complete response or partial response (RECIST1.1).
Proportion of patients without PD or death at Week 16
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
Area under the plasma concentration-time curve from time 0 to infinity (if data permit)
Maximum observed plasma concentration
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity
Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration
| Arm | Type | Description |
|---|---|---|
| Surufatinib | EXPERIMENTAL | Surufatinib 300 mg, orally, once daily (QD) |
| Placebo | PLACEBO_COMPARATOR | Placebo 300 mg, orally, once daily (QD) |
| Surufatinib in combination with anti-PD-1/L1 therapy | EXPERIMENTAL | Surufatinib 250 mg orally once plus anti-PD-1/L1, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy. |
| Anti-PD-1/L1 monotherapy | EXPERIMENTAL | Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy |
| Surufatinib & Toripalimab | EXPERIMENTAL | Surufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle. |
| Cohort 1 | EXPERIMENTAL | Subjects with Normal Hepatic Function: All patients to receive study drug (Surufatinib 250mg) on Day 1 |
| Cohort 2 | EXPERIMENTAL | Subjects with Moderate Hepatic Impairment: All patients to receive study drug (Surufatnib 250mg) on Day 1 |
| Cohort 3 (if enrolled) | EXPERIMENTAL | Subjects with Mild Hepatic Impairment: All patients to receive study drug (Surufatnib 250mg) on Day 1 |
| Fed/Fasted | EXPERIMENTAL | surufatinib with food on Day 1 and surufatinib without food on Day 8 |
| Fasted/Fed | EXPERIMENTAL | surufatinib without food on Day 1 and surufatinib with food on Day 8 |
| Treatment Crossover Arm | EXPERIMENTAL | All patients will receive a single dose of surufatinib on day 1 in period 1, and a both itraconazole and single dose of surufatinib in period 2 |
| Name | Type | Description |
|---|---|---|
| Surufatinib | DRUG | Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle |
| Placebo | OTHER | Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle |
| Anti-PD-1/L1 | DRUG | Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy. |
| Toripalimab | DRUG | Toripalimab is an injection in the form of 240mg, intravenous, once three weeks. |
| Itraconazole | DRUG | Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14 |
Inclusion Criteria: 1. Adequately understand the study and voluntarily sign the Informed Consent Form; 2. Be at least 18 years old; 3. Based on central pathology review results，patients have a confirmed histologically pathology diagnosis of low- or intermediate grade (G1 or G2) advanced (unresectab...
Surufatinib is an investigational small molecule being studied for oncology indications including biliary tract cancer, advanced solid tumors, neuroendocrine tumors, and thyroid carcinoma. It is also being evaluated in patients with hepatic impairment and in healthy subjects. All completed trials were Phase 2 or Phase 1/2 studies conducted in China.
Surufatinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company has conducted multiple clinical trials of the drug in oncology indications across China.
Surufatinib is in Phase 2 clinical development. All three completed trials were Phase 2 studies, with one trial being a Phase 1/2 study. The drug is investigational and has not been approved by regulatory authorities based on the available data.
Surufatinib has completed three clinical trials: NCT02614495 in advanced medullary thyroid carcinoma and iodine-refractory differentiated thyroid carcinoma, NCT02966821 as second-line treatment in biliary tract carcinoma, and NCT04169672 as a single agent or combined with toripalimab in advanced solid tumors. A fourth trial, NCT05077384, was a Phase 1/2 study in Japanese patients.
Surufatinib is also known as Surufatinib with Nab-paclitaxel, and Gemcitabine. This alternative name refers to the drug being studied in combination with these chemotherapy agents, though the clinical trials listed focus on Surufatinib as a single agent or with toripalimab.
Surufatinib is a small molecule that targets multiple kinases involved in tumor growth and angiogenesis. It inhibits vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptor 1 (FGFR1), and colony-stimulating factor 1 receptor (CSF-1R), which are key pathways in cancer progression and immune evasion.