a study of hs-20117 combined with aumolertinib in participants with advanced non-squamous non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: hs-20117 is a fully-human egfr-met immunoglobulin g1(igg1)-like bispecific antibody. the purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of hs-20117 combined with aumolertinib in participants with epidermal growth factor receptor (egfr) mutation (exon 19 deletions \[exon 19del\] or exon 21 l858r substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc).

this is a multicenter phase ib/iii clinical study evaluating the safety, efficacy, pharmacokinetics (pk), and immunogenicity of hs-20117 in combination with aumolertinib in subjects with locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc). the study is divided into two phases, phase ib, a dose expansion study and phase iii, a confirmatory study. in the dose expansion phase (phase ib), hs-20117 will first be studied in combination with the standard dose of aumolertinib, to assess the efficacy, safety, tolerability, pk profile, and immunogenicity of hs-20117 in combination with aumolertinib in the target population, as well as to determine the recommended phase iii dose (rp3d). following confirmation of the safety and efficacy of hs-20117 in combination with aumolertinib and rp3d in phase ib, a randomized, active-controlled, open-label, multicenter phase iii study will be initiated to assess the efficacy and safety of hs-20117 in combination with aumolertinib versus aumolertinib in the target population in the confirmatory study phase.

Eligibility criteria:
inclusion criteria: * males or females aged 18 - 75 years (inclusive). * participants with newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic egfr-sensitive mutated nsclc (stage iiib/iiic/iv) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation. * agree to provide fresh or archival tumor tissue. * at least one target lesion per the recist v1.1. * ecog performance status of 0-1. * minimum life expectancy \> 12 weeks. * males or females should be using adequate contraceptive measures throughout the study. * females must not be pregnant at screening or have evidence of non-childbearing potential. * have signed informed consent form. exclusion criteria: * received or are receiving the following treatments: 1. previous or current treatment with met targeted therapy or egfr targeted antibodies or antibody-drug conjugates (adc). 2. traditional chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug. 3. local radiotherapy within 2 weeks prior to the first dose of study drug, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of study drug. 4. presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 5. major surgery within 4 weeks prior to the first dose of study drug. * presence of grade ≥ 2 toxicities due to prior anti-tumor therapy. * history of other primary malignancies. * untreated, or active central nervous system metastases. * inadequate bone marrow reserve or organ functions. * severe, uncontrolled or active cardiovascular disorders. * severe or uncontrolled systemic diseases. * severe bleeding symptoms or bleeding tendencies within 1 month prior to the first dose of study drug. * severe arteriovenous thrombosis occurred within 3 months prior to the first dose of study drug. * serious infection within 4 weeks prior to the first dose of study drug. * active infectious diseases. * interstitial lung disease (ild). * serious neurological or mental disorders. * history of hypersensitivity to any component of hs-20117 and aumolertinib or their similar drugs. * participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.

Keywords: non-small cell lung cancer hs-20117 epidermal growth factor receptor c-mesenchymal-epithelial transition bispecific antibody