Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesop… (NCT06846346) | Clinical Trial Compass
RecruitingPhase 2
Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
France88 participantsStarted 2025-11-20
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Age ≥18 years.
✓. For patients without actionable biomarker (HER2 and Claudin 18.2-negative) except for PD-L1, no prior treatment for advanced disease (cohort 1). For patients with at least one of the following actionable biomarker (PD-L1 CPS≥1, and/or HER2-positive, and/or Claudin 18.2-positive), who had received only one prior line of treatment for advanced disease (cohort 2).
✓. Adequate hematological function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥9 g/dL. Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening hematology analysis.
Exclusion criteria
✕. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\].
What they're measuring
1
Objective Response Rate assessed by central review
Timeframe: Time from inclusion to disease progression, up to 3 years
✕. 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.
✕. Major surgical procedures or serious trauma within 4 weeks prior to treatment start, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to treatment start.
✕. History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to inclusion, including but not limited to:
✕. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots), Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
✕. Nasal bleeding /epistaxis (bloody nasal discharge is allowed),