The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.
Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.
Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC)
Metastatic or locally advanced non resectable (stage IV) disease.
Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Previous or concurrent cancer that is distinct in primary site or histology from gastroesophageal cancer within 2 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)].
Patients with high microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor.
Enteral intake < 1500 kcal /d and or a weight loss > 15% of total body weight within the 6 months
Toxicities from previous treatment not resolved to grade ≤ 1 (according to the version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events [NCI-CTCAE v5.0]) before treatment start with the exception of alopecia.
UNICANCER
Lead sponsor
Summit Therapeutics
Collaborator