SI-B036: Administration by intravenous infusion for a cycle of 3 weeks.
Study summary
This study is an open-label, multicenter, dose-escalation and dose-expansion, non-randomized phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic urological tumors and other solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntarily sign the informed consent form and agree to comply with 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 urological tumors and other solid tumors;
6. Agree to provide archived tumor tissue specimens collected 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. Toxicities 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 specified 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 ≤ 1+ or ≤ 1000 mg/24h;
14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be breastfeeding; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the completion of treatment;
15. The trial participant must be willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol.
Exclusion Criteria:
1. Use of chemotherapy, biotherapy, immunotherapy, or similar treatments 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. 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 when receiving such treatment previously;
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. Diabetes mellitus with poor glycemic control;
11. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;
12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;
13. Active central nervous system (CNS) metastases;
14. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036;
15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
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 dose of the study drug;
18. Presence of pleural, abdominal, or pelvic effusion, or pericardial effusion requiring drainage and/or associated with symptoms within 4 weeks prior to the first dose of the study drug;
19. Imaging findings indicating that the tumor has invaded or encased the great thoracic vessels, pericardium, or heart;
20. Subjects with clinically significant bleeding or obvious 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 lactating women;
24. Other conditions that, in the investigator's opinion, make the subject unsuitable for participation in this clinical trial.
Primary outcome measure(s)
Phase Ia: Dose limiting toxicity (DLT) — Up to 21 days after the first dose DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Phase Ia: Maximum tolerated dose (MTD) — Up to 21 days after the first dose MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.
Phase Ib: Recommended Phase II Dose (RP2D) — Up to approximately 24 months The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B036.
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
More Sichuan Baili Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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