Actively Recruiting
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
Led by Tongji University · Updated on 2026-01-22
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 years and older but younger than 75 years
- Clinical diagnosis of non-squamous NSCLC
- Disease progression after standard therapy or intolerance/unsuitability for standard treatments or no available standard therapy
- Provide 3-5 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 allows assessable but not measurable lesions)
- ECOG performance status of 0-1
- Life expectancy of at least 12 weeks
- Hematologic function: ANC ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 9.0 g/dL
- Hepatic function: Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN without liver metastases or ≤5×ULN with liver metastases
- Renal function: Creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min if creatinine >1.5×ULN
- Coagulation: INR and APTT ≤1.5×ULN if on anticoagulants
- Use of contraception during the trial period
You will not qualify if you...
- Received other anti-tumor treatments within 4 weeks before HJ-004-02 administration
- Participation in investigational drug or device study within 4 weeks before first dose
- Need for other anti-tumor therapy during the study
- Unresolved toxicity from prior therapy above Grade 1 (except alopecia and stable chronic disease)
- Presence of histological transformation or certain gene abnormalities linked to resistance
- History of severe eye disorder or severe skin disease
- 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 HJ-004-02 or similar drugs
- Confirmed immunodeficiency or positive HIV test
- Active hepatitis B or positive syphilis antibodies
- Active tuberculosis
- Other malignancies within 5 years
- Significant cerebrovascular disorder within 6 months
- Major surgery or severe trauma within 4 weeks or expected during study
- History of interstitial lung disease
- Hemorrhagic disorders or coagulopathy
- Psychiatric illness
- Receipt of live attenuated vaccine within 28 days before or during treatment and 60 days after
- Pregnant or breastfeeding women
- Any other condition judged by investigator to hinder participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
S
Shengli Liu
CONTACT
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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