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NCT05740202
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
Conditions: Advanced Solid Tumors
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1
Enrollment: 182
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Summary
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria:Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;Histopathologically or cytologically documented advanced or metastatic malignancies;At least 1 measurable lesion conforming to RECIST 1.1 criteria;An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;Female and male patients of reproductive potential must agree to use highly effective contraception.Exclusion Criteria:Any immunostimulants administered within 4 weeks;Systemic anti-tumor therapy within 4 weeks;Any investigational cancer therapy administered within 4 weeks;Surgical procedures requiring general anesthesia within 4 weeks;History of autoimmune diseases;History of immunodeficiency;Severe infections within 2 weeks prior to the first study treatment;Clinically significant cardiovascular condition;Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;Known history of serious allergic reactions to the investigational product or its main ingredients.
Source: ClinicalTrials.gov (NCT05740202). StuddyBuddy aggregates publicly available trial information.