the safety and efficacy of multiple-dose of wj01024 in subject with advanced cancer

Conditions: Advanced Hematologic Malignancies; Advanced Solid Tumors

Summary: a clinical study of wj01024 in subjects with advanced cancer in china, to evaluate the safety, tolerability, pk and efficacy of wj01024. this study includes a dose escalation part and a dose expansion part. patients receive wj01024 on day 1 and day 3 of each week, 4 weeks as a cycle, until disease progression, or intolerable toxicity , withdrawal of consent, or end of the study, whichever occurs first.


Eligibility criteria:
inclusion criteria： 1. patients with advanced malignant neoplasms definitively diagnosed by pathology and/or cytology who have failed to respond to conventional treatment or are lacking effective treatment; 2. for patients with solid tumors, there should be evaluable or measurable tumor lesions according to recist 1.1 criteria (not for dose-climbing phase); 3. males and females ≥ 18 and ≤ 75 years of age,ecog performance status of 0\~1; 4. life expectancy ≥3 months; 5. the functions of the major organs were basically normal, and the following laboratory tests were performed within 7 days before the first administration of the study drug (no blood transfusion or colony-stimulating factor was administered within 14 days before the examination); 6. for premenopausal women who are likely to have children, a pregnancy test must be performed within 7 days before the first use of the study drug. the blood pregnancy test must be negative and must be non-lactating.all enrolled patients (both male and female) should take adequate barrier contraception throughout the treatment period and 3 months after the end of treatment; 7. voluntary participant in this drug clinical trial, able to understand and sign the informed consent. exclusion criteria 1.pregnant or lactating women; 2.suffer from other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, uncontrolled hypertension and thromboembolic disease); 3.there was active graft rejection at the time of enrollment (after allogeneic stem cell transplantation); 4.who is not suitable for the study after laboratory examination (blood routine, urine routine, blood biochemical, blood coagulation function) or as judged by the study physician; 5.≥ grade 2 toxicity after previous treatment;6.patients with grade 2 or more neuropathy; 7.a person suffering from an uncontrollable mental illness; 8.have a history of drug abuse or urine drug screening positive; 9.heart disease: new york heart association (nyha) \> class ii congestive heart failure, unstable angina (resting angina symptoms), new angina (within 6 months before entering the study), into the group of the first six months of myocardial infarction, or need anti-arrhythmic treatment for arrhythmia (allows the use of beta blockers, calcium channel blockers and digoxin); 10.alcoholics or those who consume more than 28 units of alcohol per week (1 unit = 285 ml beer or 25 ml spirits (40%v/v) or 1 glass \[100ml\] of wine); 11.patients with active hepatitis b, hepatitis c, hiv (+) and syphilis antibody (+);patients with hbsag or core antibody (hbcab) positivity need to be tested for hbv-dna, and hbv-dna is lower than the upper limit of normal to be enrolled.patients with hepatitis c virus antibody (hcv ab) positive should be tested for hcv rna, and those below the upper limit of normal can be enrolled. 12.requiring long-term corticosteroids or other immunosuppressive therapy, such as those who have had organ transplants; 13.other conditions considered ineligible by the investigator.