Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Insufficient wash out duration of prior systemic anticancer therapy
Local radiotherapy within 2 weeks prior to first dose of investigational drug
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.
Clareo Health | A Phase Ib Study of HS-10504 Combined Therapy in NSCLC
