Lung Cancer
Conditions
Keywords
Lung cancer, Tyrosine Kinase Inhibitor, Immuno-Checkpoint Inhibitor, Antibody Drug Conjugate
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).
Detailed description
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combination therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). A dose exploration stage of each combination therapy will be conducted in subjects with advanced or metastatic NSCLC patients who experienced disease progression (PD) on or after prior treatments, to explore appropriate doses. In addition, an dose-expansion stage will be conducted in appropriate target populations based on the data obtained in the dose exploration stage to further explore the safe and efficacy.
Interventions
DRUGHS-20122+Aumolertinib
EGFR mut NSCLC, receive HS-20122+Aumolertinib
DRUGHS-20122+Adbrelimab
EGFRwt NSCLC,receive HS-20122+Adbrelimab
DRUGHS-20122+Adbrelimab+Platinum-based Chemo
EGFR wt NSCLC,receive HS-20122+Adbrelimab+ Platinum-based Chemo
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D for Combination | Through the full duration of this trial, approximately 2 years | To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-20122 based therapy in subjects with locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial |
| ORR | Through the full duration of this trial, approximately 2 years； | Investigator evaluated overall response rate, to evaluate the efficacy of each combination; |
| TEAE | Through the full duration of this trial, approximately 2 years； | incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0 |
| TRAE | Through the full duration of this trial, approximately 2 years； | incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0 |
| SAE | Through the full duration of this trial, approximately 2 years | incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | Through the full duration of this trial ,approximately 2 years | Investigator evaluated Duration of Response |
| Disease Control Rate | Through the full duration of this trial ,approximately 2 years； | Investigator evaluated Disease Control Rate |
| Progression Free Survival | Through the full duration of this trial, approximately 2 years； | Investigator evaluated duration of Progression Free Survival |
| Overall Survival | Through the full duration of this trial ,approximately 2 years； | Investigator evaluated duration of Overall Survival |
| PK parameter | Through the full duration of this trial, approximately 2 years； | blood concentration of combo agents |
| Immuogencity | Through the full duration of this trial ,approximately 2 years； | positive rate of drug specific antibody |
Countries
China
Outcome results
None listed