HS-20122 combination therapy in NSCLC (Phase 1b)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label Phase 1b study in adults with NSCLC to examine the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of HS-20122 when given with Aumolertinib, Adbrelimab, or both with platinum-based chemotherapy. The study includes a dose exploration stage to identify safe dose levels in patients whose cancer progressed after prior therapy, followed by a dose-expansion stage in selected groups. The trial will enroll participants with adequate organ function and good performance status (ECOG 0-1) who have at least one measurable lesion per RECIST 1.1.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ethics Committee of Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.