HS-20117: 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)
Aumolertinib: 110 mg orally once daily.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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, major surgery or other local therapy within washout period to the first dose of study drug.
3. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
4. Other investigational non-anti-tumor drugs, strong CYP3A4 inhibitors, strong inducers, drugs that are sensitive substrates of BCRP or P-gp, or drugs that prolong the QT interval within the washout period.
* 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.
* Severe arteriovenous thrombosis occurred.
* Serious or active infection.
* 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.
* Female subjects who are pregnant, lactating, or planning to become pregnant or breastfeed during the study period or within 6 months after the last dose of the study drug.
* Subjects with a history of severe allergic reactions or those who have experienced severe infusion reactions
* Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
Primary outcome measure(s)
[Phase Ib] Objective response rate (ORR) According to response evaluation criteria in solid tumors (RECIST) v1.1 by Investigators (INVs) — From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months ORR is defined as the percentage of participants with DOR of confirmed CR or confirmed PR per RECIST v1.1
[Phase III] Progression-Free Survival (PFS) According to RECIST v1.1 by Independent Review Committee(IRC) — Up to approximately 40 months PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1
Trial sites (2)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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