A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

Launched by HANSOH BIOMEDICAL R&D COMPANY · May 12, 2024

Keywords

ClinConnect Summary

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 comb...

Gender

ALL

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.

Trial Officials