Actively Recruiting
A Randomized Controlled Phase III Study Comparing BL-M05D1 Injection With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Prior First-Line Treatment
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-06-04
438
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of BL-M05D1 in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma that is positive for Claudin 18.2. This Phase III, randomized, open-label, multicenter trial focuses on patients who have already undergone prior first-line treatment and aims to compare BL-M05D1 with other common chemotherapy options. The study is led by Sichuan Baili Pharmaceutical Co., Ltd. and aims to provide new options for patients with these advanced cancers. Participants in this study will be randomly assigned to receive either BL-M05D1 or an investigator-chosen chemotherapy regimen which includes paclitaxel, docetaxel, or irinotecan hydrochloride. BL-M05D1 is given by intravenous infusion every 3 weeks. In the comparator group, paclitaxel is infused every 4 weeks, docetaxel every 3 weeks, and irinotecan hydrochloride every 2 weeks. Those who show clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons for stopping treatment occur. During the trial, participants will be closely monitored with assessments including overall survival and progression-free survival up to approximately 24 months. Other measures include response rates, duration of response, and treatment-related adverse events. Tumor tissue samples will be collected, and participants must have measurable lesions. Regular evaluations will help track the disease and safety of treatments. The study will last as long as needed to gather data, with safety and efficacy followed throughout and after treatment periods.
CONDITIONS
Brief Title
A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study rules
- No gender restrictions
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
- Evidence of tumor progression after prior first-line standard therapy
- Ability to provide archived or fresh tumor tissue
- At least one measurable tumor lesion by RECIST v1.1
- ECOG performance status of 0 or 1
- Recovery from prior treatment toxicities to Grade 1 or less
- No severe cardiac dysfunction with LVEF of 50% or higher
- Organ functions meet required levels
- Coagulation parameters within specified limits
- Urine protein levels within acceptable range
- Negative pregnancy test for premenopausal women and use of effective contraception during and 6 months after treatment
You will not qualify if you...
- Prior anti-tumor treatment not meeting protocol
- Positive HER2 expression in tumor tissue
- History of severe cardiovascular or cerebrovascular disease
- Certain heart rhythm problems or arrhythmias
- Unstable thrombotic events within 6 months before screening
- Active autoimmune or inflammatory diseases
- Other malignancies diagnosed within 3 years prior to treatment
- Poorly controlled hypertension despite medication
- History of interstitial lung disease requiring hormone therapy
- Severe lung disease causing respiratory problems
- Recent infections needing clinical intervention
- Poorly controlled blood glucose levels
- Active central nervous system metastases
- Large or symptomatic serous cavity effusions
- Tumor invasion or encasement of major blood vessels
- Allergies to recombinant humanized or chimeric antibodies or BL-M05D1 components
- Prior organ or stem cell transplantation
- Active infections such as HIV, tuberculosis, hepatitis B or C
- Pregnant or breastfeeding women
- Recent esophageal or gastric varices requiring intervention
- History of intestinal obstruction or extensive bowel surgery
- Other serious medical or laboratory conditions affecting safety or study results
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable, based on individual response until disease progression or discontinuation
Participants receive intravenous drug treatment cycles. Participants in the experimental group receive BL-M05D1 every 3 weeks. Participants in the control group receive investigator's choice of paclitaxel every 4 weeks, docetaxel every 3 weeks, or irinotecan hydrochloride every 2 weeks. Treatment continues until disease progression, intolerable toxicity, or other reasons.
Repeated visits for each treatment cycle (every 2 to 4 weeks depending on assigned treatment)
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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