AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced… (NCT06196697) | Clinical Trial Compass
RecruitingPhase 2
AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer
China50 participantsStarted 2024-04-10
Plain-language summary
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
✓. Imaging examination confirmed unresectable locally advanced or metastatic gastric cancer (GC) or gastroesophageal binding cancer (GEJC), and histopathologically confirmed adenocarcinoma, with at least one measurable tumor lesion (spiral CT or MR scan ≥10mm, gonorrhea The short diameter of sling is ≥15mm, which meets the RECIST 1.1 standard); the lesion that has received radiotherapy is not selected as the target lesion, unless the radiotherapy lesion is the only measurable lesion and is clearly advanced according to imaging judgment, it can be considered as the target lesion;
✓. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months；
✓. HER2 is negative. HER2 negative is defined as: IHC 0/1+, or IHC 2+ and FISH/ISH negative (HER2: CEP17 ratio \<2). FISH can be replaced by locally available and accepted ISH methods (such as DISH);
✓. The study allowed the inclusion of Subjects with gastric cancer with peritoneal metastasis (imaging results or ascites/abdominal lavage cytology test positive);
✓. Expected survival period \> 3 months;
✓. ECOG score: 0-1;
Exclusion criteria
✕. Have good organ function (subsists are not allowed to receive blood transfusion or growth factor support treatment within 7 days before the first administration):
✕. known as squamous carcinoma, undifferentiated cancer or other tissue types of gastric cancer, or adenocarcinoma mixed with other tissue types of gastric cancer;
✕. HER2 positive stomach cancer patients: define IHC 3+, or IHC 2+ and FISH/ISH positive;
✕. Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies to ICOS, CD40, CD137, GITR, OX40 targets, etc.) , immune cell therapy and other treatment of any immune mechanism for tumors;
✕. In the first 14 days of randomization, there is still uncontrollable pleural hydration and ascites after puncture drainage and other treatments. Imaging shows that a small number of or medium chest and ascites patients can be selected for the study;
✕. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months;
✕. There are significant clinical bleeding symptoms or clear bleeding tendencies within 1 month before the first administration, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis;
✕. There are clinically active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction;