Locally Advanced or Metastatic NSCLCPhase 1/2NCT05662670
A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer
A Phase 1/2 study testing WJ13404 tablets in people with Locally Advanced or Metastatic NSCLC, run by Suzhou Junjing BioSciences Co., Ltd. at 1 site in China.
Trial summary
This is an open-label phase I/II preliminary study, including dose escalation, dose expansion, and efficacy expansion, to evaluate drug safety, tolerability, PK, and efficacy. The dose escalation study evaluates the IMP's safety, tolerability, and PK in patients with locally advanced or metastatic NSCLC who have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- What is being tested?
- WJ13404 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2022to 9 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old, male or female;
- Histologically or cytologically confirmed locally advanced or recurrent/metastatic advanced NSCLC that is inoperable, is subject to progression or intolerability after the standard of care, or is unable to be treated or has not been treated by the standard of care;
- Dose escalation: patients with EGFR sensitive mutation who have experienced disease progression after third-generation EGFR-TKI therapy;
- Dose expansion and efficacy expansion: patients with proven EGFR C797X mutation;
- Patients who agree to provide tumor tissues and blood samples for EGFR mutation analysis (certain patients who are unable to provide qualified tumor tissues may be enrolled once approved by investigators and the Sponsor);
- At least one measurable lesion as per RECIST v1.1;
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- ECOG PS score of 0-1;
- Expected survival of more than 12 weeks;
- Sufficient vital organ functions at screening (requiring no blood transfusion, use of hematopoietic stimulating factor, or use of human albumin preparation within 14 days before screening):
- ANC ≥ 1.5 × 109/L;
- Platelet ≥ 100 × 109/L;
- Hemoglobin > 90 g/L;
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.0 × upper limit of normal (ULN) (in the presence of liver metastasis, ≤ 5 × ULN);
- Total bilirubin (TBIL) ≤ 1.5 × ULN;
- Coagulation function (INR) ≤ 1.5 × ULN;
- Blood creatinine ≤ 1.5 × ULN or creatinine clearance (Ccr, calculated by the Cockcroft-Gault formula) ≥ 45 mL/min;
- Serum lipase and amylase ≤ 1.5 × ULN;
- Females with childbearing potential and a negative serum pregnancy test within 7 days before enrollment who agree to use effective contraception during the IMP treatment and 6 months after the last dose. This protocol defines "females with childbearing potential" as sexually mature women who: 1) have not undergone a hysterectomy or bilateral ovariectomy; 2) have not had spontaneous menopause for 24 consecutive months (i.e., no menstrual bleeding at any time within the last 24 consecutive months; amenorrhea after cancer treatment does not indicate infertility). Male patients whose sexual partners are females with childbearing potential must agree to use effective contraception during the study treatment and 6 months after the last dose;
- Patients who voluntarily participate in this study and have signed the informed consent form after an all-inclusive informed consent process.
Who cannot join
- Patients who have received systemic anti-tumor therapy within 4 weeks before the first dose, including chemotherapy, targeted therapy, anti-vascular drug therapy, biologic therapy, immunotherapy, radiotherapy, or other IMP therapy; moreover, patients who have received EGFR-TKI targeted therapy may be enrolled if 5 half-lives have passed after discontinuation;
- Patients who are receiving strong CYP3A inhibitors or inducers; or those who have yet to reach 5 half-lives after discontinuation of a strong inhibitor, or 5 half-lives or 14 days (whichever is longer) after discontinuation of a strong inducer at the time of the first WJ13404 dosing;
- Patients who have experienced adverse events caused by previous anti-tumor therapy that have yet to improve to CTCAE v5.0 grade ≤ 1 at screening (except for neurotoxicity and alopecia, which cannot be recovered as assessed by investigators);
- Patients who are plagued by other malignancies (except for non-melanoma basal or squamous cell carcinoma of the skin, carcinoma in situ of the breast/cervix, superficial bladder cancer, thyroid cancer, and other carcinomas in situ, treated with curative intent and without evidence of recurrent disease) concurrently or within 5 years before treatment initiation;
- History of diseases causing chronic diarrhea, including but not limited to Crohn's disease and irritable bowel syndrome;
- Active gastrointestinal disease or other conditions that may significantly compromise drug absorption, metabolism, or excretion;
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- Patients known to have undergone organ transplantation or stem cell transplantation; patients who have undergone major surgery or serious trauma within 4 weeks before the first dose (excluding needle biopsy for sample collection);
- Patients who are suffering from carcinomatous meningitis and spinal cord compression;
- Patients who meet one of the following cardiac criteria: Unexplained or cardiovascular-caused presyncope or syncope, ventricular tachycardia, ventricular fibrillation, or cardiac arrest, with average corrected QT interval (based on 3 ECGs taken at rest, QTc, using the Fridericia's correction formula) > 450 ms in males or > 470 ms in females. Various clinically significant cardiac rhythm, conduction, or resting ECG morphological abnormalities, such as complete left bundle branch block, third-degree conduction block, second-degree conduction block, PR interval > 250 ms, and echocardiography-suggested left ventricular ejection fraction (LVEF) < 50%. Various factors that may increase the risks of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, history of immediate family members with long QT syndrome or sudden death of unknown cause before age 40, and current receipt of any drug known to prolong the QT interval;
- Unstable systemic diseases, such as active infection requiring systemic drug therapy, poorly controlled hypertension, unstable angina, congestive heart failure, serious hepatic, renal, or metabolic conditions including cirrhosis, renal failure, and uremia;
- Patients who experience dyspnea or require continuous oxygen therapy, or who are suffering from CTCAE v5.0 grade ≥ 2 active pneumonitis or interstitial lung disease (except mild radiation pneumonitis);
- Central nervous system metastasis with symptoms. Patients who have received treatment for brain metastases may be considered for enrollment, provided that no disease progression confirmed by radiologic imaging evaluation occurs within 4 weeks before the first dose of the IMP, no evidence shows new or enlarging brain metastases, and radiation, surgery, or steroid therapy has been discontinued for at least 4 weeks before the first dose of the IMP;
- HBV-RNA > upper limit of the reference value when positive for hepatitis B surface antigen or hepatitis B core antibody;
- HCV-RNA > upper limit of the reference value when positive for hepatitis C antibody;
- Positive for human immunodeficiency virus (HIV);
- Patients with a confirmed history of mental disorders who are receiving drugs for treatment;
- History of substance or drug abuse;
- Patients who have received traditional Chinese medicine for anti-tumor therapy within 1 week before the first dose of the study treatment;
- Previous serious eye disorders that have not recovered to grade ≤ 1;
- Skin toxicity at > grade 2 within 4 weeks before the first dose;
- Pregnancy and lactation;
- Other factors, as evaluated by investigators, that have potential effects on study results and may interfere with the patient's participation, including previous or existing physical conditions (such as eye disorders, including corneal ulcers and conjunctivitis), treatment or laboratory test abnormalities, patient unwillingness to abide by the study procedures, restrictions, and requirements, and the presence of psychological or social conditions that may interfere with their participation or affect the study result evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ13405 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer
This is an open-label phase I/II preliminary study, including dose escalation, dose expansion, and efficacy expansion, to evaluate drug safety, tolerability, PK, and efficacy. The dose escalation study evaluates the IMP's safety, tolerability, and PK in patients with locally advanced or metastatic NSCLC who have experienced disease progression after third-generation EGFR-TKI therapy. The dose expansion study, after 2-3 dose levels are selected based on dose escalation results, further investigates the IMP's safety, tolerability, and PK, explores preliminary efficacy, and determines RP2D in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation. The efficacy expansion study evaluates the IMP's safety and efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation.
- Conditions
- Locally Advanced or Metastatic NSCLC
- Being tested
- WJ13404 tablets
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WJ13404 tabletsDrug
Dose escalation: 6 dose levels The dose escalation study is proposed to include 6 dose levels: 30, 90, 180, 270, 360, and 480 mg once daily.
(It can be adjusted based on clinical PK data and safety results after discussion between PI and the sponsor).
Dose-expansion: After the initial data evaluation, the Sponsor and the SMC will select 2-3 dose levels to evaluate drug safety and PK further, explore its preliminary efficacy, and determine RP2D.
Efficacy expansion: The RP2D determined in dose escalation and dose expansion will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:WJ13404 tablets | Experimental | Dose escalation: 6 dose levels The dose escalation study is proposed to include 6 dose levels: 30, 90, 180, 270, 360, and 480 mg once daily.
(It can be adjusted based on clinical PK data and safety results after discussion between PI and the sponsor).
Dose-expansion: After the initial data evaluation, the Sponsor and the SMC will select 2-3 dose levels to evaluate drug safety and PK further, explore its preliminary efficacy, and determine RP2D.
Efficacy expansion: The RP2D determined in dose escalation and dose expansion will be applied. Receives: Drug: WJ13404 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events（AE) and serious adverse events（SAE)
To evaluate incidence，severity and outcome of adverse events（AE),and serious adverse events（SAE)
Measured: up to 3 years
ORR
Proportion of patients who have the best response of confirmed or partial response as per RECIST v1.1.ORR, along with its 95% CI, will be calculated
Measured: up to 3 years
DLT
DLT is defined as any of the following toxicities that occur during the DLT observation and are deemed by investigators possibly, probably, or definitely related to WJ13404 as per NCI-CTCAE v5.0
Measured: up to 2 years (only for dose escalation and dose expansion）
Secondary outcomes (20)
Cmax
It's suitable for dose escaltion and does extension ,maximum plasmaconcentration
Measured: up to 3 years
Tmax
It's suitable for dose escaltion and does extension,time to Cmax
Measured: up to 3 years
AUC 0-t
It's suitable for dose escaltion and does extension,area under the concentration versus time curve from time 0 to the last measurable concentration.
Measured: up to 3 years
t1/2
It's suitable for dose escaltion and does extension, elimination half-life.
Measured: up to 3 years
CL/F
It's suitable for dose escaltion and does extension, clearance.
Measured: up to 3 years
Vd/F
It's suitable for dose escaltion and does extensionapparent volume of distribution
Measured: up to 3 years
λz
It's suitable for dose escaltion and does extension, elimination rate constant.
Measured: up to 3 years
Css-min
It's suitable for dose escaltion and does extension,minimum concentration at steady state.
Measured: up to 3 years
Css-max
It's suitable for dose escaltion and does extension,maximum concentration at steady state.
Measured: up to 3 years
Css-ave
It's suitable for dose escaltion and does extension, average concentration at steady state.
Measured: up to 3 years
AUCtau-ss
It's suitable for dose escaltion and does extension,area under the concentration versus time curve for a dosing interval at steady state.
Measured: up to 3 years
Vss
It's suitable for dose escaltion and does extension,volume of distribution at steady state.
Measured: up to 3 years
AR
It's suitable for dose escaltion and does extension,accumulation ratio.
Measured: up to 3 years
DF
It's suitable for dose escaltion and does extension,degree of fluctuation.
Measured: up to 3 years
ORR
It's suitable for dose escaltion and does extension, objective response rate.
Measured: up to 3 years
DOR
It's suitable for dose escaltion and does extension, duration of response.
Measured: up to 3 years
DCR
It's suitable for dose escaltion and does extension, disease control rate.
Measured: up to 3 years
PFS
It's suitable for dose escaltion and does extension, progression-free survival.
Measured: up to 3 years
OS
It's suitable for dose escaltion and does extension,overall survival.
Measured: up to 3 years
adverse events（AE) and serious adverse events（SAE)
To evaluate incidence，severity and outcome of adverse events（AE),and serious adverse events（SAE)
Measured: up to 1 years（only for efficacy expansion stage）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start11 Oct 2022
- Primary completion1 Oct 2023
- Study completion9 Apr 2024
Why it stopped: Due to the adjustment of the R\&D strategy, Suzhou Junjing Biosciences Co., Ltd. decided to terminate this study in September 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic NSCLCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Junjing BioSciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662670
- Sponsor's protocol ID
- JS113-001-I
- Status last verified
- Aug 2025
- First submitted
- 11 Nov 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ13405 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05662670
- Acronym / sponsor ID
- JS113-001-I
- Conditions
- Locally Advanced or Metastatic NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the adjustment of the R\&D strategy, Suzhou Junjing Biosciences Co., Ltd. decided to terminate this study in September 2023
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Suzhou Junjing BioSciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 22 Dec 2022 (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.
This is an open-label phase I/II preliminary study, including dose escalation, dose expansion, and efficacy expansion, to evaluate drug safety, tolerability, PK, and efficacy. The dose escalation study evaluates the IMP's safety, tolerability, and PK in patients with locally advanced or metastatic NSCLC who have experienced disease progression after third-generation EGFR-TKI therapy. The dose expansion study, after 2-3 dose levels are selected based on dose escalation results, further investigates the IMP's safety, tolerability, and PK, explores preliminary efficacy, and determines RP2D in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation. The efficacy expansion study evaluates the IMP's safety and efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:WJ13404 tablets | Experimental | Drug: WJ13404 tabletsDose escalation: 6 dose levels The dose escalation study is proposed to include 6 dose levels: 30, 90, 180, 270, 360, and 480 mg once daily. (It can be adjusted based on clinical PK data and safety results after discussion between PI and the sponsor). Dose-expansion: After the initial data evaluation, the Sponsor and the SMC will select 2-3 dose levels to evaluate drug safety and PK further, explore its preliminary efficacy, and determine RP2D. Efficacy expansion: The RP2D determined in dose escalation and dose expansion will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Aged ≥ 18 years old, male or female;
- Histologically or cytologically confirmed locally advanced or recurrent/metastatic advanced NSCLC that is inoperable, is subject to progression or intolerability after the standard of care, or is unable to be treated or has not been treated by the standard of care;
- Dose escalation: patients with EGFR sensitive mutation who have experienced disease progression after third-generation EGFR-TKI therapy;
- Dose expansion and efficacy expansion: patients with proven EGFR C797X mutation;
- Patients who agree to provide tumor tissues and blood samples for EGFR mutation analysis (certain patients who are unable to provide qualified tumor tissues may be enrolled once approved by investigators and the Sponsor);
Key exclusion criteria (22 listed)
- Patients who have received systemic anti-tumor therapy within 4 weeks before the first dose, including chemotherapy, targeted therapy, anti-vascular drug therapy, biologic therapy, immunotherapy, radiotherapy, or other IMP therapy; moreover, patients who have received EGFR-TKI targeted therapy may be enrolled if 5 half-lives have passed after discontinuation;
- Patients who are receiving strong CYP3A inhibitors or inducers; or those who have yet to reach 5 half-lives after discontinuation of a strong inhibitor, or 5 half-lives or 14 days (whichever is longer) after discontinuation of a strong inducer at the time of the first WJ13404 dosing;
- Patients who have experienced adverse events caused by previous anti-tumor therapy that have yet to improve to CTCAE v5.0 grade ≤ 1 at screening (except for neurotoxicity and alopecia, which cannot be recovered as assessed by investigators);
- Patients who are plagued by other malignancies (except for non-melanoma basal or squamous cell carcinoma of the skin, carcinoma in situ of the breast/cervix, superficial bladder cancer, thyroid cancer, and other carcinomas in situ, treated with curative intent and without evidence of recurrent disease) concurrently or within 5 years before treatment initiation;
- History of diseases causing chronic diarrhea, including but not limited to Crohn's disease and irritable bowel syndrome;
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 |
|---|---|---|
| WJ13404 tabletsDose escalation: 6 dose levels The dose escalation study is proposed to include 6 dose levels: 30, 90, 180, 270, 360, and 480 mg once daily. (It can be adjusted based on clinical PK data and safety results after discussion between PI and the sponsor). Dose-expansion: After the initial data evaluation, the Sponsor and the SMC will select 2-3 dose levels to evaluate drug safety and PK further, explore its preliminary efficacy, and determine RP2D. Efficacy expansion: The RP2D determined in dose escalation and dose expansion will be applied. | Drug | Experimental:WJ13404 tablets |
Primary outcome
adverse events（AE) and serious adverse events（SAE)
Time frame: up to 3 years
To evaluate incidence，severity and outcome of adverse events（AE),and serious adverse events（SAE)
ORR
Time frame: up to 3 years
Proportion of patients who have the best response of confirmed or partial response as per RECIST v1.1.ORR, along with its 95% CI, will be calculated
DLT
Time frame: up to 2 years (only for dose escalation and dose expansion）
DLT is defined as any of the following toxicities that occur during the DLT observation and are deemed by investigators possibly, probably, or definitely related to WJ13404 as per NCI-CTCAE v5.0
20 secondary outcomes
Cmax
Time frame: up to 3 years
Tmax
Time frame: up to 3 years
AUC 0-t
Time frame: up to 3 years
t1/2
Time frame: up to 3 years
CL/F
Time frame: up to 3 years
Vd/F
Time frame: up to 3 years
λz
Time frame: up to 3 years
Css-min
Time frame: up to 3 years
Css-max
Time frame: up to 3 years
Css-ave
Time frame: up to 3 years
AUCtau-ss
Time frame: up to 3 years
Vss
Time frame: up to 3 years
AR
Time frame: up to 3 years
DF
Time frame: up to 3 years
ORR
Time frame: up to 3 years
DOR
Time frame: up to 3 years
DCR
Time frame: up to 3 years
PFS
Time frame: up to 3 years
OS
Time frame: up to 3 years
adverse events（AE) and serious adverse events（SAE)
Time frame: up to 1 years（only for efficacy expansion stage）
Results and safety
The study was stopped early (reason given: Due to the adjustment of the R\&D strategy, Suzhou Junjing Biosciences Co., Ltd. decided to terminate this study in September 2023). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WJ13404 tablets in people with Locally Advanced or Metastatic NSCLC, 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 19 inclusion and 22 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 8 Sep 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: Due to the adjustment of the R\&D strategy, Suzhou Junjing Biosciences Co., Ltd. decided to terminate this study in September 2023). 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?
adverse events（AE) and serious adverse events（SAE) (time frame: up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.