Clinical trial NCT04991129: The Safety and Efficacy of Multiple-dose of WJ01024 in Subject With Advanced Cancer
Official title: A Dose Escalation and Dose Expansion Study of WJ01024 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy for Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Hematologic Malignancies
Advanced Solid Tumors
Lead sponsor: Suzhou Junjing BioSciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
timeFrame: 2 years
Secondary outcomes:
measure: ORR
timeFrame: 2 years
measure: DOR
timeFrame: 2 years
measure: DCR
timeFrame: 2 years
measure: PFS
timeFrame: 2 years
measure: Cmax
timeFrame: 2 years
measure: Tmax
timeFrame: 2 years
measure: AUC0-t
timeFrame: 2 years
measure: AUC0-inf
timeFrame: 2 years
measure: Kel
timeFrame: 2 years
measure: t1/2
timeFrame: 2 years
measure: CL/F
timeFrame: 2 years
measure: Vd/F
timeFrame: 2 years
measure: Rac
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin The First Hospitall
state: Heilongjiang
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: 北京市
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: