This is an open-label, single-arm, dose-escalation, multicenter phase I/II clinical trial. The primary endpoints of this study were to evaluated the safety, tolerability, pharmacokinetic profile and preliminary efficacy of HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy. The secondary endpoints of this study were to evaluated the efficacy HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy.
Sign written informed consent before implementing any trial-related procedures;
Age ≥18 years old;
No limit on the gender;
Histological or cytological confirmed advanced or metastatic non-small cell lung cancer, ineligible for radical surgery, relapse after failure of previous treatment with first-line (including first, second, and third generation)EGFR inhibitors.
Subjects treated with CYP isozyme inducers or inhibitors (see Appendix 4 for details) within 3 weeks prior to enrollment;
Pregnant or lactating women;
History of immunodeficiency or other acquired, congenital immunodeficiency diseases;
Patients with prior bone marrow transplantation or prior solid organ transplantation;
Parallel
LMV-12(HE003)
Drug1 cycle was 28 days. LMV-12(HE003), 30mg or 60mg, continuously for 21 days, and the drug was discontinued for 7 days. Osimertinib, 80mg, continuously for 28 days.
ORR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Adverse event and safety
Number of participants experiencing clinical and laboratory adverse events (AEs)
PFS
Progression free survivaltime, define as first dose to the disease progression death of the subject due to any cause
OS
Overral survival time, define as first dose to the death of the subject due to any cause
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