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

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Esophageal Cancer; Gastric Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody

Participants received SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

Group Type: EXPERIMENTAL

SI-B003

Intervention Type: DRUG

Administered by intravenous infusion every 3 weeks (Q3W).

BL-B01D1

Intervention Type: DRUG

Administered by intravenous infusion for a cycle of 3 weeks.

PD-1 Monoclonal Antibody

Intervention Type: DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

SI-B003

Administered by intravenous infusion every 3 weeks (Q3W).

Intervention Type: DRUG

BL-B01D1

Administered by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

PD-1 Monoclonal Antibody

Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Other Intervention Names

iza-bren; izalontamab brengitecan; BMS-986507

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+8615013238943

Facility Contacts

Lin Shen

Role: primary

Other Identifiers

BL-B01D1-SI-B003-201-05

Identifier Type: -

Identifier Source: org_study_id