A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

HS-20117-301

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).

2024-06-01

2026-06-01

2030-06-01

Not yet recruiting

Early phase I

1080

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1080, 'type': 'ESTIMATED'}}

2024-05-20