Advanced Solid Tumor
Conditions
Interventions
Experimental group:pemigatinib
Sponsors
Jilin Provice Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; There is no gender limitation; 2. Histological or cytological evidence of unresectable advanced, recurrent or metastatic solid tumors; 3. According to RECIST v1.1, there was at least one measurable lesion; 4. Histologically confirmed FGFR1-3 variants, including but not limited to amplification, mutation, fusion/rearrangement, etc.; 5. After standard treatment, the disease progresses, becomes intolerable or fails to respond to standard treatment, or there is no standard treatment plan; 6. No previous use of small molecule multi-target inhibitors involving FGFR pathway (including allotinib, Romatinib, sorafenib, apatinib, etc.); 7. ECOG physical status is 0-1; 8. Expected survival time >3 months; 9. Adequate organ function, subject shall meet the following laboratory criteria: (1) The absolute value of neutrophil granulocyte (ANC) >=1.5x10^9/L in the last 14 days without the use of granulocyte colony stimulating factor; (2) Platelets >=100x10^9/L without blood transfusion in the last 14 days; (3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or erythropoietin use; (4) Total bilirubin ULN but direct bilirubin =50 ml/min; (7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the subject is on anticoagulant therapy, as long as PT is within the prescribed anticoagulant drug range; 10. For female subjects of childbearing age, a negative urine or serum pregnancy test should be administered within 3 days prior to the first study drug administration (day 1 of Cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Non-childbearing women were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after the last study drug administration (or 180 days after the last chemotherapeutic drug administration).
Exclusion criteria
Exclusion criteria: 1. Malignant diseases diagnosed within 5 years prior to the initial administration of the drug other than those diagnosed in the current cohort (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radical excision carcinoma in situ); 2. Past treatment with selective FGFR inhibitors; 3. Receiving any other investigational drug therapy or participating in an interventional clinical investigator within 28 days prior to initial dosing; Or received antitumor drugs (including Chinese herbal medicines with antitumor indications) within 28 days prior to the first use of the study drug; 4. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ULN; (2) The serum calcium exceeds the normal range, or when the serum albumin exceeds the normal range, the serum albumin corrected calcium concentration exceeds the normal range; (3) Potassium level 2000IU/ml or 10^4 copies /ml; Hepatitis C virus (HCV) RNA> 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies are both positive. Those who were lower than the above criteria after nucleotide antiviral therapy could be included in the group; 12. Clinically significant or uncontrolled heart disease, including unstable angina, acute myocardial infarction within 6 months prior to initial administration, New York Heart Association Class III/IV congestive heart failure, and uncontrolled arrhythmia in subjects who are permitted to wear a pacemaker or with atrial fibrillation and whose heart rate is well controlled; 13. There are ECG changes or medical histories that are considered clinically significant by the investigator; Screening QTcF interval >480 ms, for subjects with indoor conduction block (QRS interval >120 ms), JTc interval can be used instead of QTc interval (if JTc is used instead of QTc, JTc must be 160 mmHg or diastolic blood pressure >100 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopath
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Provice Cancer Hospital
Outcome results
None listed