NCT06586294CompletedPhase 1/2
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
A Phase Ib/II Open Label,Dose Escalation and Dose Extension Study Evaluating the Safety, Tolerability, and Initial Antitumor Efficacy of Anti-PD-1 and Lymphocyte Activation Gene 3(LAG-3) Bispecific Antibody AK129 Combined With Chemotherapy With or Without Cadonilimab in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Negative Unresectable Locally Advanced or Metastatic G/GEJ Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 4 Sept 2024
- Start date
- 30 Sept 2024
- Primary completion date
- 20 Apr 2026
- Lead sponsor
- Akeso
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06586294
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 35
- From 30 Sept 2024 to the primary completion date, 20 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- There was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.
Other illness
- 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.
Other
- Subjects with known HER2 positive gastric or gastroesophageal junction adenocarcinoma.
- Histopathological examination confirmed other pathological types.
- The presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hanzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.