Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
Brief summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment.
Detailed description
In this trial, the experimental group receives BL-M05D1, with each treatment cycle lasting 3 weeks. The control group receives investigator-selected treatment regimens: paclitaxel, docetaxel, or irinotecan.
Interventions
DRUGBL-M05D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGPaclitaxel
Administration by intravenous infusion for a cycle of 4 weeks.
DRUGDocetaxel
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGIrinotecan hydrochloride
Administration by intravenous infusion for a cycle of 2 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. No gender restrictions; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; 6. Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression; 7. Ability to provide archived or fresh tumor tissue; 8. Must have at least one measurable lesion as defined by RECIST v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 12. Organ function levels must meet the requirements; 13. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN); 14. Urine protein ≤2+ or \<1000 mg/24h; 15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test negative, and must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion.
Exclusion criteria
1. Prior anti-tumor treatment; 2. Positive HER2 expression in tumor tissue; 3. History of severe cardiovascular or cerebrovascular disease; 4. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias; 5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; 6. Active autoimmune diseases and inflammatory diseases; 7. Diagnosis of another malignancy within 3 years prior to the first dose; 8. Hypertension poorly controlled by two antihypertensive medications; 9. History of interstitial lung disease (ILD) requiring hormone therapy, etc.; 10. Concurrent pulmonary disease resulting in clinically severe respiratory impairment; 11. Infection requiring clinical intervention within 2 weeks prior to randomization; 12. Patients with poorly controlled blood glucose levels; 13. Patients with active central nervous system metastases; 14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions; 15. Imaging findings indicating tumor invasion or encasement of major blood vessels such as those in the chest, neck, or pharynx; 16. History of allergic reactions to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Active infection requiring systemic treatment; 20. Pregnant or breastfeeding women; 21. Esophageal or gastric varices requiring intervention within the past three months, etc.; 22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.; 23. Presence of other serious physical or laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 24 months | Overall survival (OS) is defined as the time between the subject's randomization date and subject's death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 24 months | Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. |
| Objective Response Rate (ORR) | Up to approximately 24 months | Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS). |
| Disease Control Rate (DCR) | Up to approximately 24 months | Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria. |
| Duration of Response (DOR) | Up to approximately 24 months | Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death. |
| Time to Response (TTR) | Up to approximately 24 months | Time to Response (TTR) is defined as the time from randomization to the first documented response (CR or PR) according to RECIST v1.1 criteria. |
| Treatment Emergent Adverse Event (TEAE) | Up to approximately 24 months | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M05D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M05D1. |
| Anti-drug antibody (ADA) | Up to approximately 24 months | Frequency of anti-BL-M05D1 antibody (ADA) will be investigated. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed