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A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors

RecruitingPhase 2Ages 18 Years - 75 YearsAllSuzhou Suncadia Biopharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subject has provided informed consent prior to initiation of any study-procedures 2. Age from 18 to 75 years old at the time of signing the informed consent 3. Histologically or cytologically confirmed solid tumors 4. At least one measurable lesion was identified per RECIST 1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Has a life expectancy of at least 3 months. 7. Adequate organ function 8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug Exclusion Criteria: 1. Subjects with active central nervous system (CNS) metastasis. 2. Subjects with a history of malignant tumors within 5 years prior to the first dose 3. Subjects with uncontrolled cancer pain. 4. Subjects with severe cardiovascular disease. 5. Subjects with clinically significant hemorrhage 6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion 7. Subjects highly suspected of interstitial lung disease 8. Subjects with serious infection within 4 weeks prior to the first dose 9. Known history of human immunodeficiency virus (HIV),active hepatitis B virus or hepatitis C virus infection. 10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1 11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose 12. Subjects who received major surgery within 4 weeks prior to the first dose 13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose. 14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period 15. Known allergic to any component of investigational drugs 16. 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. 17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,
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What it tests

  • SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
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Where

1 site
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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