Evaluating WJ01024 for patients with advanced cancer

A Dose Escalation and Dose Expansion Study of WJ01024 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy for Patients With Advanced Cancer

This study is testing a new drug called WJ01024 to see if it can help people in China with advanced cancer feel better and tolerate the treatment.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Junjing BioSciences Co., Ltd. (industry)
• Locations: 4 sites (Guangzhou, Guangdong and 3 other locations)
• Trial ID: NCT04991129 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and efficacy of WJ01024 in patients with advanced hematologic malignancies and solid tumors in China. It involves a dose escalation and expansion approach, where patients receive the drug on specific days each week for a cycle of four weeks, continuing until disease progression or intolerable side effects occur. The study aims to assess the tolerability and pharmacokinetics of WJ01024, alongside its effectiveness in treating advanced cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced cancer that has not responded to conventional treatments.

Not a fit: Patients with early-stage cancer or those who have not yet undergone conventional treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancer who have exhausted other treatment avenues.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for advanced cancers.

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.

Where this trial is running

Guangzhou, Guangdong and 3 other locations

• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• Harbin The First Hospitall — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Jilin Cancer Hospital — Changchun, Jilin, China (RECRUITING)
• Beijing Cancer Hospital — Beijing, 北京市, China (RECRUITING)

Study contacts

• Principal investigator: Ruihua Xu, MD — Sun Yat-sen University
• Study coordinator: Jun Ma, Doctor

Conditions: Advanced Hematologic Malignancies, Advanced Solid Tumors