Phase
Condition
Neoplasms
Treatment
SHR-4849
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 highlyeffective contraception from the time they provided written informed consent until 6months after the last dose of the trial drug
Exclusion
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 pericardialeffusion
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 orhepatitis 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 tothe first dose.
Female subjects who were pregnant, lactating, or planned to become pregnant duringthe study period
Known allergic to any component of SHR-4849 products
Alcohol abuse, drug abuse, other serious medical conditions (including mentalillness) requiring combined treatment, and other conditions that may affect subjectsafety or data collection.
Based on the investigator's judgment, subjects with other conditions that may affectstudy results, interfere with study procedures,
Study Design
Connect with a study center
Jilin Cancer Hospital
Jilin, Changchun
ChinaActive - Recruiting

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