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

NCT ID: NCT04991129

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2025-05-28

Brief 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.

Conditions

Advanced Hematologic Malignancies; Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WJ01024 5mg QD repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

5mg QD: WJ01024, Q4W, once per day

WJ01024 5mg BID repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

5mg BID: WJ01024, Q4W, twice per day

WJ01024 10mg BID repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

10mg BID: WJ01024, Q4W, twice per day

WJ01024 40mg BIW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

40mg BIW: WJ01024, Q4W, twice per week

WJ01024 60mg BIW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

60mg BIW: WJ01024, Q4W, twice per week

WJ01024 80mg BIW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

80mg BIW: WJ01024, Q4W, twice per week

WJ01024 60mg QW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

60mg QW: WJ01024, Q4W, once per week

WJ01024 80mg QW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

80mg QW: WJ01024, Q4W, once per week

WJ01024 50mg QW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

50mg QW: WJ01024, Q4W, once per week

WJ01024 40mg QW repeat dose every 28 days

Group Type: EXPERIMENTAL

WJ01024

Intervention Type: DRUG

40mg QW: WJ01024, Q4W, once per week

Interventions

WJ01024

5mg QD: WJ01024, Q4W, once per day

Intervention Type: DRUG

WJ01024

5mg BID: WJ01024, Q4W, twice per day

Intervention Type: DRUG

WJ01024

10mg BID: WJ01024, Q4W, twice per day

Intervention Type: DRUG

WJ01024

40mg BIW: WJ01024, Q4W, twice per week

Intervention Type: DRUG

WJ01024

60mg BIW: WJ01024, Q4W, twice per week

Intervention Type: DRUG

WJ01024

80mg BIW: WJ01024, Q4W, twice per week

Intervention Type: DRUG

WJ01024

60mg QW: WJ01024, Q4W, once per week

Intervention Type: DRUG

WJ01024

80mg QW: WJ01024, Q4W, once per week

Intervention Type: DRUG

WJ01024

50mg QW: WJ01024, Q4W, once per week

Intervention Type: DRUG

WJ01024

40mg QW: WJ01024, Q4W, once per week

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Junjing BioSciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruihua Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Harbin The First Hospitall

Harbin, Heilongjiang, China

Jilin Cancer Hospital

Changchun, Jilin, China

Countries

China

Other Identifiers

JJSW-01

Identifier Type: -

Identifier Source: org_study_id