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Locally Advanced or Metastatic Malignant Solid TumorsPhase 1/2NCT05326035

A Study of WJ05129 in Advanced Malignant Solid Tumors

A Phase 1/2 study testing WJ05129 and Paclitaxel injection in people with Locally Advanced or Metastatic Malignant Solid Tumors, run by Suzhou Junjing BioSciences Co., Ltd. at 1 site 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

This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with locally advanced or metastatic malignant solid tumors in China, which was divided into three stages: Single-dose escalation,Combined dose extension and efficacy extension. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
WJ05129 and Paclitaxel injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteChina
Study dates
19 Apr 2022to 26 Dec 2023
Phase
Phase 1/2
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

  • Willing to participate in the clinical trial of this drug, able to understand and sign informed consent, willing and able to comply with the planned visit and study procedures;
  • Age ≥18 to 75 years old, male and female;
  • Locally advanced (except for patients who can be treated with radical therapy) or metastatic malignant solid tumors confirmed by histology or cytology;
  • The single-dose escalation phase requires patients who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment options；The combined dose escalation phase and the efficacy expansion phase require no treatment with taxane drugs for metastatic diseases, with no more than 4 lines of treatment, and meet one of the following conditions:
  • SCLC: After receiving a platinum-based standard chemotherapy regimen for first-line treatment, whether in localized stage (LS) or extensive stage (ES), there has been progression;
  • TNBC: After receiving first-line standard treatment, previous adjuvant taxane treatment is allowed, provided that the disease-free interval from (new) adjuvant chemotherapy to the development of metastatic disease is ≥ 1 year;
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  • Other solid tumors: After receiving the first-line standard treatment recommended by CSCO or NCCN guidelines;
  • Eastern Cooperative Oncology Group (ECOG) Physical status score (Annex 2) 0 to 1;
  • Expected survival ≥ 12 weeks;
  • According to the Response evaluation criteria in solid Tumors (RECIST) 1.1 (Annex 4), there is at least one measurable lesion（Applicable only to the dose escalation and efficacy expansion phases of the combination treatment.）;
  • Voluntarily and informed consent to provide fresh biopsy samples before treatment. For patients unable to provide fresh biopsy samples before treatment, archived samples within 2 years can be provided (dose escalation stage is optional, dose expansion and efficacy expansion stage is mandatory);
  • Have sufficient important organ functions, and meet the following standards in laboratory examination ≤ 7 days before the first drug administration:
  • A: Blood system (transfusion and cytokine support therapy are not allowed within 14 days prior to initial administration) :
  • Hemoglobin ≥ 90 g/L;
  • Platelet count ≥ 100×109/L;
  • Absolute neutrophil count ≥ 1.5×109/L
  • B: Kidney function:
  • Serum albumin ≥30g/L. (Albumin infusion is not allowed within 14 days before administration)
  • Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 × Upper limit of normal (ULN); If liver metastasis occurred, AST/ALT ≤ 5 × ULN;
  • Serum total bilirubin ≤ 1.5 × ULN; TBIL≤3×ULN in patients with liver metastasis or Gilbert syndrome;
  • Serum creatinine (Cr) ≤1.5 TIMES ULN or creatinine clearance (calculated using the Cockcroft and Gault formula [Appendix 1]) ≥ 50 mL/min;
  • C: Coagulation function:
  • International standardized ratio (INR), prothrombin time (PT) and activated partial thrombin time (aPTT) ≤ 1.5ULN for patients who did not receive anticoagulant therapy; For those receiving anticoagulant therapy (e.g., low molecular weight heparin or warfarin), the anticoagulant dose should be stable for at least 4 weeks without dose adjustment;
  • D: Cardiovascular System:
  • According to Fridericia's standard, the QTc interval for males is ≤ 450 ms, and for females it is ≤ 470 ms;
  • A pregnancy test must be performed within 7 days before the first use of the study drug for premenopausal women who are likely to have children. The blood pregnancy test must be negative and must be non-lactation; All enrolled patients (male or female) should take adequate contraceptive measures throughout the treatment period and within 3 months after the end of treatment;

Who cannot join

  • Persons already known to be allergic to the active ingredients or excipients of the study drugs (WJ05129 tablets) ；
  • Patients previously treated with AURORA A kinase inhibitors (Alisertib, LY3295668, etc.) ；
  • Subjects who received a potent cytochrome CYP3A inhibitor or inducer within 14 days prior to initial administration and who needed to take these drugs throughout the study period;
  • Participate in other clinical studies within 4 weeks prior to initial administration, except during the follow-up period of observational (non-interventional) clinical studies or interventional studies;
  • Inability to swallow drugs orally, or having a condition that seriously affects gastrointestinal absorption as judged by the investigator;
  • Pregnant or lactating women;
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  • Two or more malignancies within 5 years prior to first administration. Except for early stage malignant neoplasms (carcinoma in situ or stage I neoplasms) that have been eradicated, such as adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma, etc.;
  • Underwent major surgery (as determined by the investigator) or was undergoing surgical recovery within 4 weeks prior to initial dosing. Anti-tumor chemotherapy (eluting for 6 weeks for the last chemotherapy with nitrosourea or mitomycin), radiotherapy, targeted therapy, hormone therapy, immunotherapy, or biotherapy within 4 weeks prior to initial administration. Receive anti-tumor or immunomodulatory TCM or Chinese adult medicine preparations within 2 weeks before the first administration;
  • Patients with symptoms of central nervous system metastasis (if asymptomatic and not currently receiving corticosteroid treatment, they are allowed to be enrolled) or primary tumor disease of the central nervous system;
  • Spinal cord compression that cannot be treated radically by surgery and/or radiotherapy, or for previously diagnosed spinal cord compression that is treated without clinical evidence of disease stability ≥1 week prior to randomization;
  • No remission of toxicity after previous antitumor therapy, i.e., no regression to the level specified in baseline, nCI-CTCAE5.0 level 0~1 (except hair loss), or inclusion/exclusion criteria. Irreversible toxicity not reasonably expected to be aggravated by the study drug (e.g., hearing loss) may be included after consultation with the medical monitor ;
  • Repeated drainage is required for third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion and abdominal effusion that cannot be controlled by drainage or other treatment;
  • Patients with active hepatitis B (chronic or acute, defined as patients with HBsAg positive at baseline and HBV DNA copy number greater than the upper limit of the normal value in the laboratory of the study center), or HCV positive (HCV Ab positive and HCV RNA positive);
  • Patients with prior HBV infection or cured hepatitis B (defined as HBcAb positive and HBsAg negative) can be enrolled. These patients should be tested for HBV DNA expression at the same time before randomization, and the copy number of HBV DNA should be lower than the upper limit of the normal value in the laboratory department of the research center.
  • Patients with POSITIVE HCV antibodies can only be enrolled if HCV RNA PCR test results are negative.
  • Known human immunodeficiency virus (HIV) positive persons;
  • Active tuberculosis patients;
  • Suffering from other serious complications (such as uncontrollable infection, uncontrollable hypokalemia, hypomagnesia, hypocalcemia, hypertension and thromboembolic diseases, etc.);
  • The patient has a history of major upper gastrointestinal surgery, active gastrointestinal disease or other diseases that may significantly affect drug absorption, metabolism or excretion;
  • Patients with grade 2 or more neuropathy;
  • Have a history of serious cardiovascular disease, including but not limited to: myocardial infarction or cerebrovascular accident within 6 months before enrollment, New York Cardiology > class II congestive heart failure, unstable angina pectoris, arrhythmia, etc.;
  • Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Receive live or attenuated live vaccine within 30 days of initial administration, or plan to receive live vaccine during the study period;
  • Mental illness, alcohol, drug or substance abuse are known;
  • As determined by the investigator, the subject has other factors that may lead to the termination of the study, such as non-compliance with the protocol, other serious diseases requiring combined treatment, serious abnormal laboratory examination, family or social factors, etc., which may affect the safety of the subject, or the collection of data and samples;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute & Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase I/II Clinical Study of WJ05129 Tablets in Patients With Locally Advanced or Metastatic Malignant Solid Tumors

This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with locally advanced or metastatic malignant solid tumors in China, which was divided into three stages: Single-dose escalation,Combined dose extension and efficacy extension. The study included screening, treatment and follow-up periods. The starting dose of this dose-escalation study was set at 2.5 mg/day. Five dose levels were preset.A more flexible "BOIN" dose escalation method was adopted. The maximum tolerated dose observation period was the first treatment cycle of single administration and multiple consecutive administrations (a total of 2 days) + 21 days = 23 days; In this stage, the two dosage levels of the injectable WJ05129 (RP2D dosage and the lower dose before RP2D) will be selected as the escalating doses for the combined use of WJ05129. The "BOIN" design will be adopted for dose escalation. Paclitaxel 80mg/m2 will be intravenously infused on days 1, 8, and 15. A 28-day cycle will be used, with the first cycle being the DLT observation period.Efficacy expansion phase: It is preliminarily planned to expand three cohorts of Rb negative TNBC and SCLC andOther solid tumors（Such as gastric and esophageal adenomas, gynecological tumors, etc.）, and recruit about 20-40 people in each cohort.

Being tested
WJ05129, Paclitaxel injection

What participants receive

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

  • WJ05129Drug

    Twice daily (except for single dose), 12 hours apart, fixed time is recommended

  • Paclitaxel injectionDrug

    80mg/m2 (The maximum dose is 80mg/m2 , and the dose can be adjusted according to the actual situation), The medication is administered on days 1, 8, and 15, and a 28-day period constitutes one cycle.

Study groups in NCT05326035
Study groupRoleWhat they receive
WJ05129 tabletsExperimentalNot described
Receives: Drug: WJ05129
WJ05129 combined with paclitaxelExperimentalNot described
Receives: Drug: WJ05129; Drug: Paclitaxel injection

What is being measured

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

  1. DLT

    It is suitable for dose escalation .DLT is defined as any of AE that SMC considers to have occurred during the DLT observation period and may be causally related to WJ05129 and meet DLTcriteria.

    Measured: 2 years

  2. The incidence of adverse events (AE) and serious adverse events (SAE) were assessed

    It is suitable for dose escalation and dose extension.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 physical examination, ECOG score, vital signs, electrocardiogram, ophthalmic tests and laboratory tests.

    Measured: 2 years

  3. MTD

    Defined as the dose level at which the estimated toxicity probability is closest to the target toxicity probability during the DLT observation period

    Measured: 2 years

  4. RP2D

    RP2D will be determined based on a combination of safety, tolerability, PK and/or pharmacodynamic studies .

    Measured: 2 years

  5. Incidence of Treatment-Emergent Adverse Events

    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 physical examination, ECOG score, vital signs, electrocardiogram, ophthalmic tests and laboratory tests.

    Measured: 2 years

  6. ORR

    It is suitable for the curative effect development stage.Objective Response Rate by RECIST 1.1.

    Measured: 2 years

Secondary outcomes (12)

  1. Cmax

    Maximum Plasma Concentration

    Measured: 2 years

  2. Tmax

    It is suitable for dose escalation and dose extension.Time to Cmax

    Measured: 2 years

  3. AUC0-t

    It is suitable for dose escalation and dose extension.Area under the concentration versus time curve from time 0 to the last measurable concentration

    Measured: 2 years

  4. AUC0-inf

    It is suitable for dose escalation and dose extension.AUC from time 0 to infinity

    Measured: 2 years

  5. t1/2

    It is suitable for dose escalation and dose extension.Elimination half life time

    Measured: 2 years

  6. CL/F

    It is suitable for dose escalation and dose extension.Clearance

    Measured: 2 years

  7. Vd/F

    It is suitable for dose escalation and dose extension.Apparent volume of distribution

    Measured: 2 years

  8. λz

    It is suitable for dose escalation and dose extension.elimination rate constant

    Measured: 2 years

  9. DOR

    Duration of response

    Measured: 2 years

  10. DCR

    Disease Control Rate

    Measured: 2 years

  11. PFS

    Progression-free survival

    Measured: 2 years

  12. OS

    Overall survival

    Measured: 2 years

Timeline

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

  1. First posted13 Apr 2022
  2. Study start19 Apr 2022
  3. Primary completion26 Dec 2023
  4. Study completion26 Dec 2023

Why it stopped: The sponsor terminated the study on the basis of the current data and the company's research and development strategy

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05326035
Sponsor's protocol ID
JS112-001-I
Status last verified
Sep 2025
First submitted
23 Feb 2022
Last updated
2 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing WJ05129 and Paclitaxel injection in people with Locally Advanced or Metastatic Malignant Solid Tumors, run by Suzhou Junjing BioSciences Co., Ltd. at 1 site 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 26 inclusion and 25 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: The sponsor terminated the study on the basis of the current data and the company's research and development strategy). 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?

DLT (time frame: 2 years). The study lists 6 primary outcomes in all. 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 NCT05326035.

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 2 Oct 2025.

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