Status:
NOT_YET_RECRUITING
A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma
Lead Sponsor:
Akeso
Conditions:
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma
Eligibility Criteria
Inclusion
- The subject must sign the written informed consent form(ICF) voluntarily.
- Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
- Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).
- Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.
Exclusion
- Subjects with known HER2 positive gastric or gastroesophageal junction adenocarcinoma.
- Histopathological examination confirmed other pathological types.
- Had received palliative local therapy for non-target lesions within 2 weeks before the first administration.
- Past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune cell therapy and any treatment targeting the immune mechanism of tumor action.
- History of gastrointestinal perforation and fistula within 6 months before the first dose.
- Active or previously documented inflammatory bowel disease,inability to swallow, malabsorption syndrome.
- Active malignancy within the last 3 years.
- Active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia meningeal disease are known to exist.
- The presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage.
- There was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT06586294
Start Date
September 10 2024
End Date
July 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China, 310005