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Due to a change in the development strategy, the sponsor decided to terminate the study on May 28, 2025
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WJ01024 5mg QD repeat dose every 28 days | Experimental |
| |
| WJ01024 5mg BID repeat dose every 28 days | Experimental |
| |
| WJ01024 10mg BID repeat dose every 28 days | Experimental |
| |
| WJ01024 40mg BIW repeat dose every 28 days | Experimental |
| |
| WJ01024 60mg BIW repeat dose every 28 days | Experimental |
| |
| WJ01024 80mg BIW repeat dose every 28 days | Experimental |
| |
| WJ01024 60mg QW repeat dose every 28 days | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WJ01024 | Drug | 5mg QD: WJ01024, Q4W, once per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | DLT, MTD, RP2D, Number of participants and severity with treatment-related Adverse events as assessed by CTCAE V5.0 | 2 years |
| DOR | Duration of Response |
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Inclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Sun Yat-Sen University Cancer Center |
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Sequential
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| WJ01024 80mg QW repeat dose every 28 days |
| Experimental |
|
| WJ01024 50mg QW repeat dose every 28 days | Experimental |
|
| WJ01024 40mg QW repeat dose every 28 days | Experimental |
|
| WJ01024 |
| Drug |
5mg BID: WJ01024, Q4W, twice per day |
|
| WJ01024 | Drug | 10mg BID: WJ01024, Q4W, twice per day |
|
| WJ01024 | Drug | 40mg BIW: WJ01024, Q4W, twice per week |
|
| WJ01024 | Drug | 60mg BIW: WJ01024, Q4W, twice per week |
|
| WJ01024 | Drug | 80mg BIW: WJ01024, Q4W, twice per week |
|
| WJ01024 | Drug | 60mg QW: WJ01024, Q4W, once per week |
|
| WJ01024 | Drug | 80mg QW: WJ01024, Q4W, once per week |
|
| WJ01024 | Drug | 50mg QW: WJ01024, Q4W, once per week |
|
| WJ01024 | Drug | 40mg QW: WJ01024, Q4W, once per week |
|
| 2 years |
| DCR | Disease Control Rate | 2 years |
| PFS | Progression-free survival | 2 years |
| Cmax | Maximum Plasma Concentration | 2 years |
| Tmax | Time to Cmax | 2 years |
| AUC0-t | Area under the concentration versus time curve from time 0 to the last measurable concentration | 2 years |
| AUC0-inf | AUC from time 0 to infinity | 2 years |
| Kel | Elimination rate constant | 2 years |
| t1/2 | Elimination half life time | 2 years |
| CL/F | Clearance | 2 years |
| Vd/F | Apparent volume of distribution | 2 years |
| Rac | Accumulation factor | 2 years |
| Guangzhou |
| Guangdong |
| 510050 |
| China |
| Harbin The First Hospitall | Harbin | Heilongjiang | 150010 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |