Overview
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection in Advanced Solid Tumors. To explore the reasonable dosage of SHR-4849 for Advanced Solid Tumors.
Eligibility
Inclusion Criteria:
- Subject has provided informed consent prior to initiation of any study-procedures
- Age from 18 to 75 years old at the time of signing the informed consent
- Histologically or cytologically confirmed advanced solid tumors
- At least one measurable lesion was identified per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Has a life expectancy of at least 3 months.
- Adequate organ function
- Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug
Exclusion Criteria:
- Subjects with active central nervous system (CNS) metastasis.
- Subjects with a history of malignant tumors within 5 years prior to the first dose
- Subjects with uncontrolled cancer pain.
- Subjects with severe cardiovascular disease.
- Subjects with clinically significant hemorrhage
- Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
- Subjects highly suspected of interstitial lung disease
- Subjects with serious infection within 4 weeks prior to the first dose
- Known history of human immunodeficiency virus (HIV),active hepatitis B virus or hepatitis C virus infection.
- The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
- Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
- Subjects who received major surgery within 4 weeks prior to the first dose
- Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
- Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
- Known allergic to any component of SHR-4849 products
- Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
- Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,