HJ-004-02 tablets for advanced non-squamous EGFR-mutant non-small cell lung cancer

A Phase l Clinical Study to Evalute the Safety,Tolerability,Pharmacokinetic Characteristics,and Preliminary Anti-tumor Efficacy of HJ-004-02 Tablets in Patients With Non-squamous Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations

This trial tests whether daily HJ-004-02 tablets are safe, how the body processes them, and whether they have anti-tumor activity in adults with advanced non-squamous non-small cell lung cancer that has EGFR mutations and progressed after standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07361237 on ClinicalTrials.gov

What this trial studies

This Phase 1, first-in-human study uses single-dose and multiple-dose oral administration to characterize safety, tolerability, and pharmacokinetics of HJ-004-02 and to look for preliminary anti-tumor activity. Single-dose dosing is given fasting with warm water and multiple dosing is once daily in 28-day cycles, with dose adjustments guided by emerging data. Enrolled patients must have non-squamous NSCLC with EGFR mutations, measurable or assessable lesions per RECIST v1.1, and provide archived tumor slides. The protocol includes regular clinical, laboratory, and imaging assessments at Shanghai East Hospital to monitor adverse events, drug levels, and tumor response.

Who should consider this trial

Good fit: Adults aged 18 to 74 with non-squamous NSCLC harboring one or more EGFR mutations, measurable disease (or assessable lesions in Phase Ia), ECOG 0–1, adequate hematologic and hepatic function, and available archived tumor tissue are the intended participants.

Not a fit: Patients with squamous-cell histology, no EGFR mutations, poor performance status, significant organ dysfunction, inability to provide required tumor tissue, or who cannot attend the Shanghai site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HJ-004-02 could provide an additional oral treatment option for patients with EGFR-mutant non-squamous NSCLC who have exhausted or cannot use standard therapies.

How similar studies have performed: Other oral EGFR-targeted drugs have improved outcomes in EGFR-mutant NSCLC, but HJ-004-02 is a novel agent and its safety and efficacy in humans remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Male or female, aged \>=18 years and \<75 years
2. Clinical diagnosis of NSCLC.
3. Subjects must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy.
4. Subjects must provide 3-5 archived tumor tissue slides
5. Subjects must have non-squamous NSCLC with one or more positive EGFR mutations
6. At least one measurable lesion according to RECIST v1.1 (In Phase Ia, lesions that are assessable but not measurable are acceptable).
7. ECOG performance status score of 0-1
8. Life expectancy \>=12 weeks.
9. (1) Hematologic Function:Absolute neutrophil count (ANC) \>= 1.5×10\^9/L;Platelet count (PLT) \>= 100×10\^9/L;Hemoglobin (HGB) \>=9.0 g/dL; (2)Hepatic Function:Total bilirubin (TBIL) \<=1.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) For those without liver metastases, \<=2.5 × ULN, orFor those with liver metastases, \<=5 × ULN; (3)Renal Function:Creatinine \<=1.5 × ULN; if \>1.5 × ULN, creatinine clearance ≥50 mL/min \[Creatinine clearance calculated using the Cockcroft-Gault formula (see Appendix 2: Cockcroft-Gault Formula)\] (4)Coagulation Panel Note: For subjects receiving anticoagulant therapy, the investigator will determine whether the international normalized ratio (INR) and activated partial thromboplastin time (APTT) are within a safe therapeutic range. INR \<= 1.5×ULN;APTT \<= 1.5×ULN.
10. Contraception is required during the trial period.

Exclusion Criteria:

1. Within the four weeks prior to the administration of HJ-004-02 tablets, the patient had received other anti-tumor treatments such as biological therapy, immunotherapy, radiotherapy, and chemotherapy.
2. Participation in an investigational drug study with treatment or use of an investigational device within 4 weeks before the first dose of HJ-004-02 tablets. 3. Anticipated need for any other form of anti-tumor therapy during the study.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shengli Liu

Conditions NSCLC