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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991129
• Other study ID #: JJSW-01
• Status: Recruiting
• Phase: Phase 1
• Start date: September 10, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: Suzhou Junjing BioSciences Co., Ltd.
• Contact: Jun Ma, Doctor
• Phone: 0451-84883437
• Email: mjun[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hematologic Malignancies
• Advanced Solid Tumors
• Hematologic Neoplasms

Intervention

Drug:
• WJ01024
5mg QD: WJ01024, Q4W, once per day
• WJ01024
5mg BID: WJ01024, Q4W, twice per day
• WJ01024
10mg BID: WJ01024, Q4W, twice per day
• WJ01024
40mg BIW: WJ01024, Q4W, twice per week
• WJ01024
60mg BIW: WJ01024, Q4W, twice per week
• WJ01024
80mg BIW: WJ01024, Q4W, twice per week
• WJ01024
60mg QW: WJ01024, Q4W, once per week
• WJ01024
80mg QW: WJ01024, Q4W, once per week
• WJ01024
50mg QW: WJ01024, Q4W, once per week
• WJ01024
40mg QW: WJ01024, Q4W, once per week

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	???
China	Jilin Cancer Hospital	Changchun	Jilin
China	Harbin The First Hospitall	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Junjing BioSciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR	DLT, MTD, RP2D, Number of participants and severity with treatment-related Adverse events as assessed by CTCAE V5.0	2 years
Secondary	DOR	Duration of Response	2 years
Secondary	DCR	Disease Control Rate	2 years
Secondary	PFS	Progression-free survival	2 years
Secondary	Cmax	Maximum Plasma Concentration	2 years
Secondary	Tmax	Time to Cmax	2 years
Secondary	AUC0-t	Area under the concentration versus time curve from time 0 to the last measurable concentration	2 years
Secondary	AUC0-inf	AUC from time 0 to infinity	2 years
Secondary	Kel	Elimination rate constant	2 years
Secondary	t1/2	Elimination half life time	2 years
Secondary	CL/F	Clearance	2 years
Secondary	Vd/F	Apparent volume of distribution	2 years
Secondary	Rac	Accumulation factor	2 years