Advanced solid tumor or lymphoma
Conditions
Interventions
Case series:NHWD-870 HCl
Sponsors
Department of Oncology, Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form voluntarily, understand the research and be willing to follow and have the ability to complete all the experimental procedures; 2. For patients with advanced malignant tumors that have been clearly diagnosed by pathology and/or cytology, tumor type criteria: (1) Relapsed/refractory non-Hodgkins lymphoma (NHL) confirmed by histology that has received at least two previous systemic treatments and meets the following criteria:-Meets the systemic treatment criteria according to the GELF criteria and has no criteria for rescue Follicular lymphoma (FL) available for treatment options; -Have received at least two treatment options in the past (for example, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone [R- CHOP]) relapsed or refractory diffuse large B-cell lymphoma-unspecified type (DLBCL NOS, 2016 World Health Organization Lymphoma Classification), and is not a candidate for standard salvage treatments or autologous/alogenous stem cell transplantation; (2) The solid tumor meets the following criteria: it is confirmed by histology or cytology as a late-stage recurrent or metastatic solid tumor. According to RECIST v1.1, there is at least one evaluable tumor lesion; the standard treatment has failed, or there is no standard treatment plan; 3. Aged 18 to 75 years old at the time of screening; 4. The Eastern Cooperative Oncology Group (ECOG) score (see Appendix 1) with a physical fitness score of 0 to 1; 5. Those whose expected survival time is> 3 months; 6. The functions of major organs are basically normal, and the following laboratory tests during the screening period must meet all the criteria: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L; (2) Absolute white blood cell count (WBC) >=3.0x10^9/L; (3) Platelet count >=100x10^9/L; (4) Hemoglobin (HB) >=9 g/dL (patients must not receive blood transfusion or other blood products within 14 days before the screening period); (5) Coagulation function: International normalized ratio (INR) 50ml/min (calculated according to Cockcroft-Gault formula); 7. Male subjects and female subjects of childbearing age should agree to take effective contraceptive measures approved by the investigator within 3 months after signing the informed consent form until the last administration.
Exclusion criteria
Exclusion criteria: 1. Those suffering from other serious complications (such as uncontrollable infection, myocardial infarction within 6 months, uncontrollable hypertension and thromboembolic diseases, etc.); 2. Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judges it to be unsuitable for inclusion (except for patients with stable brain metastasis control after whole brain radiotherapy); 3. Have a history of serious cardiovascular disease, including but not limited to: (1) Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia that requires clinical intervention, II-III degree atrioventricular block, etc.; (2) In the resting state, the average QTcF>450ms obtained from 3 12-lead ECG examinations; (3) Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of grade 3 or above occurred within 6 months before the first administration; (4) The New York College of Cardiology (NYHA)>Class II or left ventricular ejection fraction (LVEF)103), hepatitis C or HIV(+); 15. Long-term treatment with high-dose corticosteroids or other immunosuppressive agents is required, such as those who have undergone organ transplantation, or have received systemic glucocorticoids (such as prednisone>10mg/day or Equivalent doses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD/RP2D;DLT incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators;Efficacy index;Biomarker index; | — |
Countries
China
Contacts
Public ContactXiang Chen
Xiangya Hospital of Central South University
Outcome results
None listed