Clinical trial · Interventional
Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-012 at single doses and multiple doses .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sulfatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sulfatinib capsule
- description
- cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle.
- interventionNames
- Drug: Sulfatinib
Primary outcomes (1)
- measure
- To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
- timeFrame
- 1-28days after every drug administration
- description
- 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
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: •≥ 18 and ≤ 70 years of age * Histological or cytological confirmed solid malignant tumor * ECOG performance status of 0-2 * Standard regimen failed or no standard regimen available * Life expectancy of more than 12 weeks * LVEF ≥ 50% Exclusion Criteria: * Pregnant or lactating women * Adequate hepatic, renal, heart, and hematologic functions (platelets \<75 × 109/L, neutrophil \<1.5 × 109/L, hemoglobin \< 90g/dl ,serum creatinine within upper limit of normal(ULN), total bilirubin and serum transaminase within upper limit of normal(ULN), and PT, APTT, TT, Fbg normal * Any factors that influence the usage of oral administration * Evidence of uncontrolled CNS metastasis * Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure * Abuse of alcohol or drugs * Less than 4 weeks from the last clinical trial * Previous treatment with VEGF/VEGFR inhibition * Disability of serious uncontrolled intercurrence infection * Uncontrolled hemorrhage in GI * Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc. * Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG * Bone fracture or wounds that was not cured for a long time * Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy
References
Publications (0)
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