NCT07678970 A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 10 participants in total. It began in 2026-07-30 with a primary completion date of 2028-12.

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily sign the informed consent form and agree to follow the protocol requirements; 2. No gender restriction; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Locally advanced or metastatic digestive tract tumors and other solid tumors; 6. Agree to provide archived tumor tissue specimens within 2 years from the primary or metastatic lesion, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 11. Organ function levels must meet the protocol requirements; 12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN); 13. Urine protein ≤2+ or ≤1000 mg/24 h; 14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must not be breastfeeding; all enrolled patients (regardless of male or female) should use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion; 15. Trial participants are capable of and willing to comply with the visit schedules, treatment plans, laboratory tests, and other study-related procedures as stipulated in the study protocol. Exclusion Criteria: 1. Use of chemotherapy, biotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose; 2. Receipt of immunosuppressive medications within 2 weeks prior to the first dose; 3. History of severe cardiac or cerebrovascular disease; 4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 5. Active autoimmune diseases and inflammatory diseases; 6. Prior history of ≥ 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 events requiring therapeutic intervention within 6 months prior to the first dose; 9. Uncontrolled hypertension; 10. Diabetic patients with poorly controlled blood glucose; 11. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis; 12. Concurrent pulmonary disease resulting in severe impairment of respiratory function; 13. Patients with active central nervous system (CNS) metastases; 14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036; 15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Positive for human immunodeficiency virus (HIV) antibodies, 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 study drug administration; 18. Presence of pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration; 19. Imaging findings indicating that the tumor has invaded or encased the major thoracic blood vessels; 20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening; 21. History of fistula, gastrointestinal perforation, or 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 lactating women; 24. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial.

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