NCT07645222 PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 396 participants in total. It began in 2026-06-15 with a primary completion date of 2028-10-31.

Brief Summary

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).

Eligibility Criteria

Inclusion Criteria: 1. Locally advanced or metastastic NSCLC; 2. Received at least 1 line SoC,or treatment naïve; 3. With at least 1 target lesion according to RECIST 1.1. 4. Appropriate organ function 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose. 6. Minimum expected survival longer than 12 weeks 7. 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. 8. Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form. Exclusion Criteria: 1. Insufficient wash out duration of prior systemic anticancer therapy 2. Local radiotherapy within 2 weeks prior to first dose of investigational drug 3. Pleural/abdominal effusion requires clinical intervention 4. Major surgery within 4 weeks prior to first dose of investigational drug 5. History of drugs may prolong QT interval 6. 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). 7. Presence of brain metastasis or carcinomatous meningtitis 8. History of other primary malignancies 9. Significant, uncontrolled, or active cardiovascular diseases 10. Severe or poorly controlled diabetes 11. Extremely obesity or emaciation 12. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose 13. Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose 14. Severe infection within 4 weeks 15. History of systemic glucocorticoids over 28 days prior to first dose of investigational drug 16. Presence of known active infectious diseases, 17. Prensence of ophthalmological abnormalities. 17.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. 20.History of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs. 21.Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.

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