Actively Recruiting
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Effects of HJ-004-02 Tablets in Patients With Non-squamous Non-small Cell Lung Cancer With EGFR Mutations
Led by Tongji University · Updated on 2026-01-22
36
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and early anti-tumor effects of HJ-004-02 tablets in patients with non-squamous non-small cell lung cancer (NSCLC) who have specific mutations in the epidermal growth factor receptor (EGFR). This Phase 1 clinical trial is designed to study patients who have progressed after standard treatments or are unable to receive them, aiming to better understand this new drug's potential in this advanced cancer type. The treatment involves taking HJ-004-02 tablets by mouth while fasting, using warm water. The study includes both single-dose and multiple-dose phases, with multiple doses taken once daily for 28-day cycles. The dosing frequency may be adjusted based on study findings. Participants will be monitored throughout these cycles to assess how the drug is tolerated and processed by the body. Participants will undergo regular evaluations including tumor assessments using standard criteria, blood tests to monitor blood cell counts and organ function, and safety checks for any adverse effects or dose-limiting toxicities. The study will monitor adverse events for about one year. Researchers will also collect archived tumor tissue samples to confirm eligibility. The total participation duration varies with the treatment cycles and follow-up assessments.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to less than 75 years
- Clinical diagnosis of non-small cell lung cancer (NSCLC)
- Disease progression after standard therapy, or intolerant, unsuitable, or no available standard therapy
- Provide 3 to 5 archived tumor tissue slides
- Non-squamous NSCLC with one or more positive EGFR mutations
- At least one measurable lesion by RECIST v1.1 (Phase Ia accepts assessable lesions)
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate hematologic function: ANC ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function: total bilirubin ≤ 1.5× ULN; ALT and AST ≤ 2.5× ULN without liver metastases or ≤ 5× ULN with liver metastases
- Adequate renal function: creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min
- Coagulation parameters within safe therapeutic range if on anticoagulants (INR ≤ 1.5× ULN; APTT ≤ 1.5× ULN)
- Use of contraception during the trial period
You will not qualify if you...
- Received other anti-tumor treatments (biological, immunotherapy, radiotherapy, chemotherapy) within 4 weeks before HJ-004-02 tablets
- Participated in another investigational drug or device study within 4 weeks before first dose
- Need for other anti-tumor therapy during the study
- Toxicity from prior therapy not resolved to Grade 1 or less (except alopecia and stable chronic disease)
- Histological transformation or certain gene abnormalities related to EGFR-TKI resistance
- History of severe eye or skin disorders
- Gastrointestinal disease
- Treatment with P-gp inhibitors or potent CYP3A4 inhibitors
- Uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage
- Symptomatic brain metastasis, meninges metastases, or spinal cord compression
- Active infection of Grade 2 or higher
- Allergy to study drug ingredients or similar drugs
- Immunodeficiency or positive HIV test
- Active hepatitis B
- Positive syphilis antibody and titer
- Active tuberculosis
- Other malignancy within 5 years prior to first dose
- Significant cerebrovascular disorder within 6 months prior
- Major surgery or severe trauma within 4 weeks prior or expected during study
- History of interstitial lung disease
- Hemorrhagic diathesis or coagulopathy
- Known psychiatric illness
- Recent live attenuated vaccine administration or planned during study and 60 days after
- Pregnant or breastfeeding females
- Any condition that may hinder study participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive HJ-004-02 tablets orally once daily while fasting. Each treatment cycle lasts 28 days, and dosing frequency may be adjusted based on study data.
Visits occur regularly during each 28-day cycle for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
S
Shengli Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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