Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tyrosine Kinase Inhibitor, HMPL-012, sulfatinib, Sulfatinb
Surufatinib · 15 trials · 22 indications
the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).
Duration from the date of initial treatment to the date of death due to any cause
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
Determine the RP2D of the pamiparib and surufatinib combination
The percentage of patients alive without documented progression 6 months after treatment initiation.
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
the safety of Sulfatinib
The primary endpoint is evaluation of safety during the first 28-day cycle 1 of therapy following the initiation of multiple dosing of HMPL-012. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate
| Arm | Type | Description |
|---|---|---|
| Surufatinib | EXPERIMENTAL | Surufatinib 300 mg, orally, once daily (QD) |
| Placebo | PLACEBO_COMPARATOR | Placebo 300 mg, orally, once daily (QD) |
| Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine | EXPERIMENTAL | - |
| Nab-paclitaxel Plus Gemcitabine | ACTIVE_COMPARATOR | - |
| Surufatinib with Nab-paclitaxel, and Gemcitabine | OTHER | - |
| 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. |
| Pamiparib + Surufatinib (Phase Ib/II) | EXPERIMENTAL | Phase Ib: A dose de-escalation schedule is used in the phase Ib dose finding part. Dose Level 1 (starting dose): pamiparib 40 mg administered orally twice daily (fixed dose) and surufatinib 250 mg administered orally once daily on a 21-day treatment cycle. If ≥2/6 patients experience a dose limiting toxicity (DLT), we will de-escalate to Dose Level 2: pamiparib 40 mg administered orally twice daily (fixed dose) and surufatinib 200 mg administered orally once daily on a 21-day treatment cycle. Approximately 3-12 patients will be enrolled in phase Ib study. Phase II: The phase II part will begin once the recommended phase 2 dose (RP2D) of surufatinib have been determined in the Phase Ib in order to assess antitumor activity of pamiparib and surufatinib combination. In phase II study, pamiparib 40 mg orally twice daily and surufatinib PR2D will be administered. |
| 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 |
| Sulfatinib | EXPERIMENTAL | Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. |
| Sulfatinib capsule | EXPERIMENTAL | cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle. |
| 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 |
| Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine | DRUG | Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8 |
| Nab-paclitaxel Plus Gemcitabine | DRUG | Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8 |
| Surufatinib with Nab-paclitaxel, and Gemcitabine | DRUG | Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8 |
| 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. |
| Surufatinib in combination with Gemcitabine | DRUG | Surufatinib in combination with Gemcitabine |
| Pamiparib | DRUG | Oral |
| Sulfatinib | DRUG | Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. |
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 in oncology for advanced solid tumors, biliary tract cancer, extensive-stage small cell lung cancer, hepatic impairment, metastatic pancreatic cancer, and neuroendocrine tumors. It is in Phase 2 development and is not yet approved for these uses.
Surufatinib targets FGFR1, FLT1, FLT4, and KDR. It acts as an inhibitor of these receptor tyrosine kinases, which are involved in angiogenesis and tumor growth signaling pathways. This multi-target inhibition is the basis for its investigation in solid tumors and other cancers.
Surufatinib is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is the sponsor of the clinical trials evaluating surufatinib in various cancer indications.
Surufatinib is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 program includes trials in metastatic pancreatic cancer, extensive-stage small cell lung cancer, and other solid tumors.
Surufatinib is being studied in several clinical trials, including NCT06361888, a Phase 2/3 trial in metastatic pancreatic cancer that is currently recruiting; NCT05509699, a completed Phase 2 trial in extensive-stage small cell lung cancer; NCT05494580, a completed Phase 1 trial in platinum-resistant ovarian cancer; and NCT05093322, a completed Phase 1/2 trial in pediatric and young adult patients with recurrent or refractory solid tumors.