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OncoMatch/Clinical Trials/NCT06846346

Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma

Is NCT06846346 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivonescimab and FOLFOX regimen for metastatic esophageal adenocarcinoma.

Phase 2RecruitingUNICANCERNCT06846346Data as of May 2026

Treatment: Ivonescimab · FOLFOX regimen · Irinotecan · PaclitaxelThe 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.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Gastric Cancer

Biomarker criteria

Required: HER2 (ERBB2) wild-type (HER2-negative)

HER2-negative

Required: CLDN18 wild-type (Claudin 18.2-negative)

Claudin 18.2-negative

Allowed: HER2 (ERBB2) overexpression

HER2-positive

Allowed: CLDN18 overexpression

Claudin 18.2-positive

Allowed: PD-L1 (CD274) overexpression

PD-L1 CPS≥1

Disease stage

Required: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 0 prior lines

Lab requirements

Blood counts

ANC ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥9 g/dL; no blood transfusion or growth factor therapy within 7 days prior to screening

Kidney function

estimated creatinine clearance ≥50 mL/min or eGFR ≥50 mL/min, urine protein < 2+ or 24-hour urine protein quantification < 1.0 g

Liver function

total bilirubin level ≤1.5 × ULN (≤3 x ULN for patients with liver metastases or confirmed/suspected Gilbert syndrome), AST and ALT ≤2.5 × ULN (≤5 x ULN when documented liver metastasis)

Adequate hematological function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥9 g/dL. Adequate renal function: estimated creatinine clearance ≥50 mL/min... Adequate liver function: total bilirubin level ≤1.5 × ULN (≤3 x ULN for patients with liver metastases or confirmed/suspected Gilbert syndrome), and AST and ALT ≤2.5 × ULN (≤5 x ULN when documented liver metastasis).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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