Advanced Hematologic MalignanciesPhase 1NCT04991129

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

A Phase 1 study testing WJ01024 in people with Advanced Hematologic Malignancies and Advanced Solid Tumors, run by Suzhou Junjing BioSciences Co., Ltd. at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Hematologic Malignancies, Advanced Solid Tumors
What is being tested?: WJ01024
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 4 sitesChina
Study dates: 10 Sep 2021to 28 May 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 ≤ 75 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.

Who cannot join

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 locations and contacts

4 sites in 1 country.

China4 sites

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jilin Cancer Hospital
Changchun, Jilin, 130012
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510050
Harbin The First Hospitall
Harbin, Heilongjiang, 150010

Other trials in China

About this study

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

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.

Conditions: Advanced Hematologic Malignancies, Advanced Solid Tumors
Being tested: WJ01024

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WJ01024Drug
5mg QD: WJ01024, Q4W, once per day
WJ01024Drug
5mg BID: WJ01024, Q4W, twice per day
WJ01024Drug
10mg BID: WJ01024, Q4W, twice per day
WJ01024Drug
40mg BIW: WJ01024, Q4W, twice per week
WJ01024Drug
60mg BIW: WJ01024, Q4W, twice per week
WJ01024Drug
80mg BIW: WJ01024, Q4W, twice per week
WJ01024Drug
60mg QW: WJ01024, Q4W, once per week
WJ01024Drug
80mg QW: WJ01024, Q4W, once per week
WJ01024Drug
50mg QW: WJ01024, Q4W, once per week
WJ01024Drug
40mg QW: WJ01024, Q4W, once per week

Study groups in NCT04991129
Study group	Role	What they receive
WJ01024 5mg QD repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 5mg BID repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 10mg BID repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 40mg BIW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 60mg BIW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 80mg BIW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 60mg QW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 80mg QW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 50mg QW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024
WJ01024 40mg QW repeat dose every 28 days	Experimental	Not described Receives: Drug: WJ01024

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 years

Secondary outcomes (13)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202128 May 2025

First posted5 Aug 2021
Study start10 Sep 2021
Primary completion28 May 2025
Study completion28 May 2025

Why it stopped: Due to a change in the development strategy, the sponsor decided to terminate the study on May 28, 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Hematologic MalignanciesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Sequential
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04991129
Sponsor's protocol ID: JJSW-01
Status last verified: Jun 2025
First submitted: 14 Jul 2021
Last updated: 26 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04991129
Acronym / sponsor ID: JJSW-01
Conditions: Advanced Hematologic Malignancies, Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to a change in the development strategy, the sponsor decided to terminate the study on May 28, 2025
Enrolment: 23 participants (actual)
Lead sponsor: Suzhou Junjing BioSciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Sep 2021 (actual)
Primary completion: 28 May 2025 (actual)
Study completion: 28 May 2025 (actual)
First posted: 5 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 10
Model description: Sequential

Arm	Type	Receives
WJ01024 5mg QD repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 5mg BID repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 10mg BID repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 40mg BIW repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 60mg BIW repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 80mg BIW repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 60mg QW repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 80mg QW repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 50mg QW repeat dose every 28 days	Experimental	Drug: WJ01024
WJ01024 40mg QW repeat dose every 28 days	Experimental	Drug: WJ01024

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 ≤ 75 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);

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WJ010245mg QD: WJ01024, Q4W, once per day	Drug	WJ01024 5mg QD repeat dose every 28 days
WJ010245mg BID: WJ01024, Q4W, twice per day	Drug	WJ01024 5mg BID repeat dose every 28 days
WJ0102410mg BID: WJ01024, Q4W, twice per day	Drug	WJ01024 10mg BID repeat dose every 28 days
WJ0102440mg BIW: WJ01024, Q4W, twice per week	Drug	WJ01024 40mg BIW repeat dose every 28 days
WJ0102460mg BIW: WJ01024, Q4W, twice per week	Drug	WJ01024 60mg BIW repeat dose every 28 days
WJ0102480mg BIW: WJ01024, Q4W, twice per week	Drug	WJ01024 80mg BIW repeat dose every 28 days
WJ0102460mg QW: WJ01024, Q4W, once per week	Drug	WJ01024 60mg QW repeat dose every 28 days
WJ0102480mg QW: WJ01024, Q4W, once per week	Drug	WJ01024 80mg QW repeat dose every 28 days
WJ0102450mg QW: WJ01024, Q4W, once per week	Drug	WJ01024 50mg QW repeat dose every 28 days
WJ0102440mg QW: WJ01024, Q4W, once per week	Drug	WJ01024 40mg QW repeat dose every 28 days

Primary outcome

The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Time frame: 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

13 secondary outcomes

ORR
Time frame: 2 years
DOR
Time frame: 2 years
DCR
Time frame: 2 years
PFS
Time frame: 2 years
Cmax
Time frame: 2 years
Tmax
Time frame: 2 years
AUC0-t
Time frame: 2 years
AUC0-inf
Time frame: 2 years
Kel
Time frame: 2 years
t1/2
Time frame: 2 years
CL/F
Time frame: 2 years
Vd/F
Time frame: 2 years
Rac
Time frame: 2 years

Results and safety

The study was stopped early (reason given: Due to a change in the development strategy, the sponsor decided to terminate the study on May 28, 2025). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruihua Xu, MD principal investigator

Sun Yat-Sen University Cancer Center

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WJ01024 in people with Advanced Hematologic Malignancies and Advanced Solid Tumors, run by Suzhou Junjing BioSciences Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to a change in the development strategy, the sponsor decided to terminate the study on May 28, 2025). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of adverse events (AE) and serious adverse events (SAE) were assessed (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04991129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.