The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Junjing BioSciences Co., Ltd.

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 ≤ 70 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."