A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

Trial Title: A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

NCT ID: NCT06008054

Condition: Esophageal Cancer
Gastric Cancer
Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Antibodies
Antibodies, Monoclonal

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SI-B003
Description: Administered by intravenous infusion every 3 weeks (Q3W).
Arm group label: SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody

Intervention type: Drug
Intervention name: BL-B01D1
Description: Administered by intravenous infusion for a cycle of 3 weeks.
Arm group label: SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody

Intervention type: Drug
Intervention name: PD-1 Monoclonal Antibody
Description: Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label: SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody

Summary: This phase II study is a clinical study to explore the efficacy and safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors.

Detailed description: To explore the efficacy, safety and tolerability of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors, and to further explore the optimal dose and combination way.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Gender is not limited; 3. Age: ≥18 years old and ≤75 years old; 4. Expected survival time ≥3 months; 5. Patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors; 6. Agreed to provide primary tumors or metastases 2 years archive of tumor tissue samples or fresh tissue samples; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG 0 or 1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. No blood transfusion, no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and organ function levels must meet the criteria; 12. Blood coagulation function: international standardization ratio of 1.5 or less, and the part activated clotting time live enzymes ULN 1.5 or less; 13. Urinary protein ≤2+ or ≤1000mg/24h; 14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Antitumor therapy such as chemotherapy or biological therapy was used within 4 weeks or 5 half-lives before the first dose in this study; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil; 2. Cohort using BL-B01D1, previously treated with an ADC drug with topoisomerase I inhibitor as toxin; Immunomodulatory drugs were administered within 2 weeks before the first dose in this study; 3. Systemic corticosteroids were required within 2 weeks before the first dose of the study; 4. Had received immunotherapy and developed grade ≥3 irAE or grade ≥2 immune-related myocarditis according to the CSCO guidelines; 5. History of severe heart disease; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block; 7. Active autoimmune and inflammatory diseases; 8. Other malignant tumors were diagnosed within 5 years before the first dose in this study; 9. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy; 10. Pulmonary disease defined as grade ≥3 according to CTCAE v5.0; The patient was diagnosed with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition. Patients with existing or a history of interstitial lung disease; 11. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded; 12. Patients with unstable pericardial effusion, pleural effusion, ascites and other serous cavity effusion; 13. Patients with active central nervous system metastasis; 14. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-B01D1 or SI-B003; 15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 16. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection; 17. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc; 18. Enrolled in another clinical trial within 4 weeks before the first dose of this study; 19. Patients who received live vaccine within 4 weeks before the first dose; 20. Patients with a history of mental illness or drug abuse who are unable to cooperate with clinical trial requirements; 21. The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Lin Shen

Start date: November 16, 2023

Completion date: December 2025

Lead sponsor:
Agency: Sichuan Baili Pharmaceutical Co., Ltd.
Agency class: Industry

Collaborator:
Agency: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Sichuan Baili Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06008054