Advanced solid tumor
Conditions
Interventions
Case series:LMV-12(HE003)
Sponsors
Cancer Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-65 years old; 2. Histological or cytologically confirmed locally advanced or metastatic solid tumors, tumor patients without standard or standard treatment failure; 3. ECOG score 0-2 points, life expectancy is not less than 12 weeks; 4. According to the RECIST1.1 solid tumor evaluation criteria, at least one imaging (CT, PET-CT, MRI) can measure or evaluate the lesion; 5. Laboratory tests for organ function levels must meet the following requirements: The absolute value of neutrophils >=1.5x10^9/L; platelet count>=100x10^9/L; hemoglobin>=9g/dL; bilirubin=60mL/min (according to Cockcroft-Gault formula); 6. For women who have fertility before menopause, they must have a pregnancy test within 7 days before starting treatment. The serum pregnancy test must be negative and must be non-lactation; all patients (whether male or female) should be treated as a whole. Take adequate barrier contraception during the period and 3 months after the end of treatment; 7. Voluntarily enroll and sign informed consent, follow the trial treatment plan and visit plan.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent any chemotherapy within 4 weeks prior to enrollment (nitrosourea or mitomycin C within 6 weeks); or used any radiation therapy or targeted anticancer drug treatment within 14 days prior to enrollment Patient 2. Uncontrolled brain metastases or patients with primary brain cancer (except for asymptomatic or symptomatic stabilization after treatment); 3. At the beginning of the study, there was still unhealed toxicity in the previous treatment, and the CTCAE grade exceeded grade 1 (except for hair loss); 4. Subjects treated with CYP isoenzyme inducers or inhibitors (see Appendix 4) for the first 3 weeks prior to screening; 5. The patient is using (or can not be stopped within 1 week before the first treatment of the study treatment) with anti-tumor as an indication of Chinese herbal medicine; 6. Pregnant or lactating women; 7. Hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive). Previous or cured HBV infections were eligible for this study only when HBV DNA was 1000 cps/mL. Hepatitis C (HCV) antibody-positive patients are eligible to participate in the study only if the polymerase chain reaction indicates HCV RNA negative; 8. Have a history of immunodeficiency, or have other acquired, congenital immunodeficiency diseases; 9. Patients who have previously undergone bone marrow transplantation or previous solid organ transplantation; 10. Patients with liver cancer; 11. Patients with gastrointestinal perforation, gastrointestinal fistula or non-gastrointestinal fistula; 12. Any factors that affect the patient's oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction; 13. Meet any of the following cardiac criteria: (1) At rest, the Bazetts mean corrected QT interval (QTc) > 470 msec (female) or > 450 msec (male) (1st time) by electrocardiogram (ECG) examination In case of abnormality, repeat 1 time within 48 hours, calculated by 2 average results); (2) various clinically significant heart rhythm, conduction, resting ECG morphological abnormalities, such as complete left bundle branch block, III degree block Hysteresis, second degree block, PR interval >250 msec; (3) with grade I or higher myocardial ischemia or myocardial infarction or grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (4) may increase QTc prolongs risk or risk of arrhythmia events, such as coronary heart disease, heart failure, hypokalemia, congenital long QT syndrome, first-degree relatives in family history have long QT syndrome or are unknown until less than 40 years old The cause is dying, and any drug known to have a prolonged QT interval is being used; 14. Patients with any severe and/or uncontrolled disease, including but not limited to the following: (1) patients with unsatisfactory blood pressure control (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg); (2) active or not Severe infection that can be controlled (>=CTCAE grade 2 infection); (3) cirrhosis, decompensated liver disease; hemodialysis or peritoneal dialysis for renal failure; (4) poor control of diabetes (fasting blood glucose (FBG)>10mmol/L); (5) urine routine indicates that urine protein >= ++, and confirmed 24-hour urine protein quantitation > 1.0 g; 15. Patients with seizures and need treatment, who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity(DLT);Maximum tolerated dose(MTD);Pharmacokinetic parameters for single and multiple administration;Physical examination, vital signs, weight, adverse events, laboratory and auxiliary examinations.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR);Progression-free survival (PFS);Duration of remission (DOR);Clinical benefit; | — |
Countries
China
Contacts
Public ContactShi Yuankai
Cancer Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed