Phase
Condition
Neoplasms
Treatment
SHR-3821 injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation and written informed consent.
18-75 years older, no gender limitation.
Eastern Cooperative Oncology Group (ECOG) score: 0-1.
With a life expectancy ≥ 3 months.
Pathologically diagnosed advanced solid tumor.
Be able to provide fresh or archived tumour tissue.
At least one measurable lesion according to RECIST v1.1.
Adequate bone marrow reserve and organ function.
Contraception is required during the trial.
Exclusion
Exclusion Criteria:
Meningeal metastasis history or clinical symptoms of central nervous systemmetastasis.
Uncontrollable tumor-related pain.
Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion withclinical symptoms.
Received systemic antitumor therapy before the first dose.
Treated with similar target therapy as SHR-3821 before the first dose.
Received systemic anticancer treatments 4 weeks prior to the initiation of the studytreatment.
Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.
Current or History of ILD.
Active severe digestive disease.
Previous or co-existing malignancies.
History of severe hypersensitivity reactions to either the drug substances orinactive ingredients of SHR-3821.
Active hepatitis B or active hepatitis C.
Other inappropriate situation considered by the investigator.
Study Design
Connect with a study center
West China Hospital of Sichuan Hospital
Chengdu, Sichuan 610000
ChinaSite Not Available
West China Hospital of Sichuan Hospital
Chengdu 1815286, Sichuan 1794299 610000
ChinaActive - Recruiting

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