Lung Cancer
Conditions
Brief summary
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Interventions
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
* Cohort1:participants with EGFR mutation advanced stage NSCLC，disease progression on or after prior treatment； * Cohort2:participants with MET position advanced stage NSCLC，disease progression on or after prior treatment； * 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 criteria
* 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, * Presence of hepatic encephalopathy, Hepantorenal Syndrome * Presence or history of confirmed or suspected ILD; * Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder. * Past 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.
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-10504 based therapy in subjects with EGFR mutation-positive 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 |
Outcome results
None listed