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โ† Trials
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A Study of SI-B036 in Patients With Locally Advanced or Metastatic Solid Tumors

RecruitingPhase 1Ages 18 Years - 75 YearsAllSichuan Baili Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This study is an open-label, multicenter, non-randomized Phase I clinical study of dose-escalation and expansion to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic solid tumors.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. No gender restriction; 3. Age: โ‰ฅ18 years and โ‰ค75 years; 4. Expected survival time โ‰ฅ3 months; 5. Locally advanced or metastatic solid tumors; 6. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 2 years or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. ECOG performance status score of 0 or 1; 9. Toxicity from prior anti-tumor therapy has recovered to โ‰ค Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction โ‰ฅ50%; 11. Organ function levels must meet the requirements; 12. Coagulation function: International Normalized Ratio โ‰ค1.5, and Activated Partial Thromboplastin Time โ‰ค1.5 ร— ULN; 13. Urine protein โ‰ค2+ or โ‰ค1000 mg/24h; 14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion; 15. The trial participant is capable and willing to adhere to the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol. Exclusion Criteria: 1. Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose; 2. Receipt of immunosuppressive therapy within 2 weeks prior to the first dose; 3. History of severe cardiac or cerebrovascular disease; 4. QT interval prolongation, complete left bundle branch block, etc.; 5. Active autoimmune diseases and inflammatory diseases; 6. Prior experience of โ‰ฅ grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment; 7. Diagnosis of another solid tumor within 5 years prior to the first dose; 8. Unstable thrombotic event requiring therapeutic intervention within 6 months prior to the first dose; 9. Poorly controlled hypertension; 10. Diabetic patients with poorly controlled blood glucose; 11. History of ILD requiring steroid therapy, or current ILD, or โ‰ฅ grade 2 radiation pneumonitis; 12. Concomitant pulmonary disease causing severe respiratory impairment; 13. Active central nervous system metastases; 14. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or hypersensitivity to any excipient component of SI-B036; 15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug; 18. Presence of pleural, abdominal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of study drug; 19. Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart; 20. Study participants with clinically significant bleeding or a clear bleeding tendency within 4 weeks prior to screening; 21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose; 22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose; 23. Pregnant or breastfeeding women; 24. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.
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What it tests

  • SI-B036
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Where

1 site
Sun Yat-sen University Cancer Center
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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