PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC

About this study

This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Condition: Lung Cancer
Tested: HS-20122+Aumolertinib, HS-20122+Adbrelimab, HS-20122+Adbrelimab+Platinum-based Chemo
Sponsor: Hansoh BioMedical R&D Company

Who can join

Age: 18 to 75 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 11

Minimum age: 18 years
Maximum age: 75 years
Study condition: Lung Cancer
Locally advanced or metastastic NSCLC;
Received at least 1 line SoC,or treatment naïve;
With at least 1 target lesion according to RECIST 1.1.
Appropriate organ function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.
Minimum expected survival longer than 12 weeks
Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.
Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.

Exclusion 20

Insufficient wash out duration of prior systemic anticancer therapy
Local radiotherapy within 2 weeks prior to first dose of investigational drug
Pleural/abdominal effusion requires clinical intervention
Major surgery within 4 weeks prior to first dose of investigational drug
History of drugs may prolong QT interval
Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).
Presence of brain metastasis or carcinomatous meningtitis
History of other primary malignancies
Significant, uncontrolled, or active cardiovascular diseases
Severe or poorly controlled diabetes
Extremely obesity or emaciation
Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose
Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose
Severe infection within 4 weeks
History of systemic glucocorticoids over 28 days prior to first dose of investigational drug
Presence of known active infectious diseases,
Prensence of ophthalmological abnormalities.
Presence of hepatic encephalopathy, Hepato-renal Syndrome 18.Presence or history of confirmed or suspected ILD; 19.Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder.
History of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs.
Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.

Where

1 site, 1 recruiting

Ethics Committee of Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Recruiting