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
Drug: AK129 Drug：oxaliplatin Drug：capecitabine: 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.
Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence and severity of adverse events(AE) — Up to approximately 2 years Incidence and severity of AEs is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR) — Up to approximately 2 years Incidence of SAE and SUSAR is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Incidence of dose-limiting toxicity(DLT) — Up to approximately 2 years The purpose of DLT is to find the Phase II recommended dose(RP2D) or Maximum Tolerated Dose(MTD)
Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension — Up to approximately 2 years Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Objective Solution Rate (ORR) based on RECIST v1.1 — Up to approximately 2 years The purpose of ORR is aim to evaluate the antitumor effect,and ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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