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

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

NCT ID: NCT06417008

Condition: Non-Squamous Non-Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Non-Small Cell Lung Cancer
HS-20117
Epidermal Growth Factor Receptor
c-Mesenchymal-Epithelial Transition
Bispecific Antibody

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HS-20117
Description: Participants will receive HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days)
Arm group label: Phase III: HS-20117 and Aumolertinib
Arm group label: Phase Ib: HS-20117 and Aumolertinib

Other name: PM1080

Intervention type: Drug
Intervention name: Aumolertinib
Description: 110 mg orally once daily.
Arm group label: Phase III: Aumolertinib
Arm group label: Phase III: HS-20117 and Aumolertinib
Arm group label: Phase Ib: HS-20117 and Aumolertinib

Other name: Almonertinib Mesilate Tablets

Other name: HS-10296

Other name: Almonertinib

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).

Detailed description: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: June 1, 2024

Completion date: June 1, 2030

Lead sponsor:
Agency: Hansoh BioMedical R&D Company
Agency class: Industry

Source: Hansoh BioMedical R&D Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06417008