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

NCT04991129 | Terminated Phase 1

• 1 other identifier: JJSW-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events (AE) and serious adverse events (SAE) were assessed

  Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests

  2 years

Secondary Outcomes (13)

• ORR

  2 years

• DOR

  2 years

• DCR

  2 years

• PFS

  2 years

• Cmax

  2 years

Study Arms (10)

WJ01024 5mg QD repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 5mg BID repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 10mg BID repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 40mg BIW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 60mg BIW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 80mg BIW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 60mg QW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 80mg QW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 50mg QW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

WJ01024 40mg QW repeat dose every 28 days

EXPERIMENTAL

Drug: WJ01024

Interventions

WJ01024 DRUG

5mg QD: WJ01024, Q4W, once per day

WJ01024 5mg QD repeat dose every 28 days

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• For patients with solid tumors, there should be evaluable or measurable tumor lesions according to RECIST 1.1 criteria (not for dose-climbing phase);
• Males and females ≥ 18 and ≤ 75 years of age,ECOG performance status of 0\~1;
• Life expectancy ≥3 months;
• 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);
• 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;
• Voluntary participant in this drug clinical trial, able to understand and sign the informed consent.

You may not qualify if:

• 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.
• Requiring long-term corticosteroids or other immunosuppressive therapy, such as those who have had organ transplants; 13.Other conditions considered ineligible by the investigator.

Sponsors & Collaborators

• Suzhou Junjing BioSciences Co., Ltd.: lead

Study Sites (4)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510050, China

Location

Harbin The First Hospitall

Harbin, Heilongjiang, 150010, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

Study Officials

• Ruihua Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 5, 2021
• Study Start: September 10, 2021
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)