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Trial Title:
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
NCT ID:
NCT06586294
Condition:
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Phase 1b/II, open-label, 2-part, multicenter, non-randomized, multiple-dose study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Drug: AK129 Drug：oxaliplatin Drug：capecitabine
Description:
AK129 is administered intravenously according to the frequency every three weeks(Q3W) and
different dosage of administration at different stages.Oxaliplatin is administered
intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine
is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice
daily on day 1 to 14 Q3W.
Arm group label:
The dose escalation and expansion stage of AK129 combined with chemotherapy;
Intervention type:
Drug
Intervention name:
Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine
Description:
AK129 is administered intravenously according to the frequency Q3W and different dosage
of administration at different stages. Cadonilimab is administered intravenously
according to the frequency and dosage 10mg/kg Q3W.Oxaliplatin is administered
intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine
is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice
daily on day 1 to 14 Q3W.
Arm group label:
The dose escalation and expansion stage of AK129 combined with chemotherapy with cadonilimab
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subject must sign the written informed consent form(ICF) voluntarily.
2. Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
3. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction
(GEJ).
4. Inoperable locally advanced or metastatic gastric or gastroesophageal junction
adenocarcinoma.
5. Participants had not previously received systemic therapy for locally advanced or
metastatic gastric or gastroesophageal junction adenocarcinoma.
6. According to RECIST v1.1 criteria, subjects had at least one measurable tumor
target.
Exclusion Criteria:
1. Subjects with known HER2 positive gastric or gastroesophageal junction
adenocarcinoma.
2. Histopathological examination confirmed other pathological types.
3. Had received palliative local therapy for non-target lesions within 2 weeks before
the first administration.
4. Past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune
cell therapy and any treatment targeting the immune mechanism of tumor action.
5. History of gastrointestinal perforation and fistula within 6 months before the first
dose.
6. Active or previously documented inflammatory bowel disease,inability to swallow,
malabsorption syndrome.
7. Active malignancy within the last 3 years.
8. Active or untreated brain metastases, meningeal metastases, spinal cord compression,
or pia meningeal disease are known to exist.
9. The presence of clinical symptoms of pleural effusion, pericardial effusion, or
abdominal effusion, or the need for frequent drainage.
10. There was an active autoimmune disease that required systemic treatment within 2
years prior to the start of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hanzhou
Zip:
310005
Country:
China
Contact:
Last name:
Xiangdong Cheng, Doctor
Phone:
0571 - 88122222
Email:
Chengxd516@126.com
Start date:
September 10, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06586294
