The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WJ01024 5mg repeat dose every 28 days
|
Drug: WJ01024
5mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 10mg repeat dose every 28 days
|
Drug: WJ01024
10mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 20mg repeat dose every 28 days
|
Drug: WJ01024
20mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 40mg repeat dose every 28 days
|
Drug: WJ01024
40mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 60mg repeat dose every 28 days
|
Drug: WJ01024
60mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 80mg repeat dose every 28 days
|
Drug: WJ01024
80mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 100mg repeat dose every 28 days
|
Drug: WJ01024
100mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 120mg repeat dose every 28 days
|
Drug: WJ01024
120mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 140mg repeat dose every 28 days
|
Drug: WJ01024
140mg: WJ01024, Q4W, twice per week
|
| Experimental: WJ01024 160mg repeat dose every 28 days
|
Drug: WJ01024
1600mg: WJ01024, Q4W, twice per week
|
Outcome Measures
Primary Outcome Measures
- The incidence of adverse events (AE) and serious adverse events (SAE) were assessed [2 years]
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
Secondary Outcome Measures
- ORR [2 years]
DLT, MTD, RP2D, Number of participants and severity with treatment-related Adverse events as assessed by CTCAE V5.0
- DOR [2 years]
Duration of Response
- DCR [2 years]
Disease Control Rate
- PFS [2 years]
Progression-free survival
- Cmax [2 years]
Maximum Plasma Concentration
- Tmax [2 years]
Time to Cmax
- AUC0-t [2 years]
Area under the concentration versus time curve from time 0 to the last measurable concentration
- AUC0-inf [2 years]
AUC from time 0 to infinity
- Kel [2 years]
Elimination rate constant
- t1/2 [2 years]
Elimination half life time
- CL/F [2 years]
Clearance
- Vd/F [2 years]
Apparent volume of distribution
- Rac [2 years]
Accumulation factor
Eligibility Criteria
Criteria
"Inclusion criteria：
-
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 ≤ 70 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.
Exclusion criteria
-
Pregnant or lactating women;
-
Suffer from other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, uncontrolled hypertension and thromboembolic disease);
-
There was active graft rejection at the time of enrollment (after allogeneic stem cell transplantation);
-
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;
-
≥ Grade 2 toxicity after previous treatment;
-
Patients with grade 2 or more neuropathy;
-
A person suffering from an uncontrollable mental illness;
-
Have a history of drug abuse or urine drug screening positive;
-
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);
-
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);
-
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;
-
Other conditions considered ineligible by the investigator."
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Harbin The First Hospitall | Harbin | Heilongjiang | China | 150010 |
| 2 | Jilin Cancer Hospital | Changchun | Jilin | China | 130012 |
| 3 | Beijing Cancer Hospital | Beijing | 北京市 | China | 100142 |
Sponsors and Collaborators
- Suzhou Junjing BioSciences Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JJSW-01