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

A Dose Escalation and Dose Expansion Study of WJ01024 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy for Patients With Advanced Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors; Advanced Hematologic Malignancies
• Intervention / Treatment: Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024; Drug: WJ01024

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jun Ma, Doctor; Phone Number: 0451-84883437; Email: mjun@csco.org.cn
• Study Contact Backup: Name: Jun Zhu, Doctor; Phone Number: 010-88196115; Email: zhujun3346@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150010
      • Not yet recruiting
      • Harbin The First Hospitall
      • Contact: Jun Ma, MD; Phone Number: 0451-84883437; Email: mjun@csco.org.cn
  • Jilin
    • Changchun, Jilin, China, 130012
      • Not yet recruiting
      • Jilin Cancer Hospital
      • Contact: Ying Cheng, MD; Phone Number: 0431-80596067; Email: jl.cheng@163.com
  • 北京市
    • Beijing, 北京市, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Zhu; Phone Number: 010-88196115; Email: zhujun3346@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

"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 ≤ 70 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."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WJ01024 5mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 10mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 20mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 40mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 60mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 80mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 100mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 120mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 140mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week
Experimental: WJ01024 160mg repeat dose every 28 days	Drug: WJ01024; 5mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 10mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 20mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 40mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 60mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 80mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 100mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 120mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 140mg: WJ01024, Q4W, twice per week; Drug: WJ01024; 1600mg: WJ01024, Q4W, twice per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival	2 years
DOR	Duration of Response	2 years
DCR	Disease Control Rate	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
ORR	DLT, MTD, RP2D, Number of participants and severity with treatment-related Adverse events as assessed by CTCAE V5.0	2 years

Collaborators and Investigators

• Sponsor: Suzhou Junjing BioSciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: JJSW-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No