Phase
Condition
Neoplasms
Treatment
Adebrelimab
Cisplatin / carboplatin
HS-20089
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females aged 18 years or older (≥18 years).
Patients diagnosed with pathologically confirmed advanced solid tumors.
Subjects have at least one target lesion as assessed per the RECIST 1.1. Patientswith only brain and/or bone lesions as target lesions are ineligible.
Agree to provide fresh or archival tumor tissue
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 andno deterioration within 2 weeks before the first dose.
Have a life expectancy of at least 12 weeks.
Female subjects of childbearing potential are willing to take appropriatecontraceptive measures and should not breastfeed from signing the informed consentuntil 6 months after the last dose; male subjects must agree to use barriercontraception (i.e. condoms) from signing the informed consent to 6 months after thelast dose.
Female subjects must have a negative pregnancy test within 7 days prior to the firstdose (for subjects with tumor related abnormal elevation of human chorionicgonadotropin [HCG], an ultrasound of uterus and appendages should be performedwithin 7 days prior to the first dose to rule out pregnancy), or demonstrate no riskfor pregnancy.
Subject must be voluntarily enrolled in this clinical trial, be able to understandthe study procedures and to sign written informed consent.
Exclusion
Exclusion Criteria:
Have received or is currently receiving the following treatment: B7-H4-targetedtherapies; Have received any of cytotoxic chemotherapy drugs, investigational drugs,anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 daysprior to the first dose of study drug; or need to continue these drugs during thestudy.
Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for AdverseEvents due to prior anti-tumor therapy.
Presence of pleural/abdominal effusion requiring clinical intervention.
Known history of other primary malignancy.
Evidence of brain metastasis and/or cancerous meningitis
Inadequate bone marrow reserve or hepatic/renal functions.
Cardiological examination abnormality.
Severe, uncontrolled or active cardiovascular disorders.
Serious or poorly controlled diabetes.
Serious or poorly controlled hypertension.
Clinically significant bleeding symptoms or significant bleeding tendency within 1month prior to the first dose of study treatment.
Serious infections within 4 weeks prior to the first dose.
Have received systemic glucocorticoid therapy for more than 7 days within 28 daysprior to the first dose study treatment, or require chronic (≥ 7 days) use ofsystemic glucocorticoids during the study, or have other acquired, congenitalimmunodeficiency disorders, or a history of organ transplantation.
Presence of active infectious diseases such as hepatitis B, hepatitis C,tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or moresevere cirrhosis.
Any moderate or severe lung diseases that may interfere with the detection andtreatment of drug-related pulmonary toxicity or may seriously affect respiratoryfunction.
History of severe neurological or psychiatric disorder.
Pregnant or breast-feeding women or women who intend to become pregnant during thestudy.
Attenuated live vaccination within 4 weeks prior to the first dose.
Subjects with autoimmune disease that is active or is likely to recur.
Subjects with gastrointestinal fistula, visceral fistula, gastrointestinalperforation, or abdominal abscess, or with symptoms/signs of intestinal obstructionwithin 6 months prior to the first dose of study drug.
Subjects unlikely to comply with study procedures, restrictions and requirement asdetermined by the investigator.
Subjects with any condition that jeopardizes the safety of the patient or interfereswith the assessment of the study, as judged by the investigator.
Study Design
Study Description
Connect with a study center
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Shanghai, Shanghai 430000
ChinaActive - Recruiting
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