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

Suzhou Junjing BioSciences

Status and phase: Terminated; Phase 1

Conditions: Advanced Hematologic Malignancies; Advanced Solid Tumors

Treatments: Drug: WJ01024

Study type: Interventional

Funder types: Industry

Identifiers

NCT04991129

JJSW-01

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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23 participants in 10 patient groups

WJ01024 5mg QD repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 5mg BID repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 10mg BID repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 40mg BIW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 60mg BIW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 80mg BIW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 60mg QW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 80mg QW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 50mg QW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

WJ01024 40mg QW repeat dose every 28 days

Experimental group

Treatment:

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024

Drug: WJ01024