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Single dose: Fasting, oral administration, as a single dose, taken with warm water. Multiple doses: Fasting, oral administration, as a single dose, taken with warm water, once daily (dosing frequency may be adjusted based on study data), with 28 days as one cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HJ-004-02-101 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HJ-004-02 tablets | Drug | Single dose: Fasting, oral administration, as a single dose, taken with warm water. Multiple doses: Fasting, oral administration, as a single dose, taken with warm water, once daily (dosing frequency may be adjusted based on study data), with 28 days as one cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Incidence and severity of adverse events (AEs) | through study completion, an average of 1 year |
| DLT | Incidence of dose-limiting toxicities (DLTs) during the DLT observation period | at the end of cycle1(each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
4. Toxicity from prior therapy has not resolved to <=Grade 1 according to NCI-CTCAE v5.0 criteria, with the exception of alopecia and long-term stable chronic disease.
5. Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance; 6. History of severe eye disorder prior. 7. History of severe dermatosis prior. 8. Subjects who have gastrointestinal disease 9. Subjects who have received treatment with P-gp inhibitors, potent CYP3A4 inhibitors 10. Subjects with uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage procedures, as judged by the investigator.
11. Subjects with symptomatic brain metastasis, metastases to meninges, or spinal cord compression.
12. Subjects with an active infection of >=Grade 2 13. Subjects with a history of allergy to the active ingredient or inactive excipients of HJ-004-02 tablets, or to drugs with a similar chemical structure or class to HJ-004-02 tablets.
14. Subjects with a confirmed immunodeficiency disease, and/or a positive HIV test result at screening.
15. Subjects with active hepatitis B 16. Subjects with positive syphilis antibodies and a positive titer test. 17. Active tuberculosis. 18. Presence of a malignancy other than the indication of this study within <=5 years before the first dose of HJ-004-02 tablets 19. Subjects who have had a clinically significant cerebrovascular disorder within 6 months before the first dose of HJ-004-02 tablets, 20. Subjects who have undergone major surgery or severe traumatic injury within 4 weeks before the first dose of HJ-004-02 tablets, or who are expected to require major surgery during the study.
21. History of interstitial lung disease (ILD) 22. Subjects with any haemorrhagic diathesis or coagulopathy 23. Subjects with a known psychiatric illness 24. Those who have received a live attenuated vaccine within 28 days before the first dose of the investigational product or plan to receive one during the study and within 60 days after the end of investigational product treatment.
25. Female subjects who are pregnant or breastfeeding. 26. Any other condition that, in the investigator's judgment, would hinder the subject's participation in the clinical study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengli Liu | Contact | 86+13855102310 | slliu@jingmedicine.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
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|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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