OncoMatch/Clinical Trials/NCT07070466
Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
Is NCT07070466 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivonescimab and 5-Fluorouracil for stomach cancer stage iv.
Treatment: Ivonescimab · 5-Fluorouracil · Oxaliplatin · Leucovorin — This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (negative)
Patients with locally tested HER2 positive tumors (HER2+) tumors are excluded.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: PD-1 inhibitor
Exception: therapy was completed > 6 months prior to the time of enrollment as part of adjuvant therapy
Prior treatment with a PD-1 or PD-L1 inhibitor is exclusionary unless this therapy was completed > 6 months prior to the time of enrollment as part of adjuvant therapy.
Cannot have received: PD-L1 inhibitor
Exception: therapy was completed > 6 months prior to the time of enrollment as part of adjuvant therapy
Prior treatment with a PD-1 or PD-L1 inhibitor is exclusionary unless this therapy was completed > 6 months prior to the time of enrollment as part of adjuvant therapy.
Lab requirements
Blood counts
ANC ≥1,500/mcL; hemoglobin > 9.0 g/dL; platelets ≥100,000/mcL
Kidney function
Creatinine ≤ institutional ULN OR GFR ≥50 mL/min; urine protein < 2+ or 24-hour protein quantification < 1.0 grams
Liver function
total bilirubin ≤ 1.5x ULN (≤3x ULN with liver metastases or Gilbert syndrome); AST/ALT ≤2.5x ULN (≤5x ULN with liver metastases)
Participants must meet the following organ and marrow function as defined below: 1. absolute neutrophil count ≥1,500/mcL 2. hemoglobin > 9.0 g/dL 3. platelets ≥100,000/mcL 4. total bilirubin ≤ 1.5x institutional upper limit of normal (ULN). For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN 5. AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN 6. Creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min. 7. Urine protein < 2+ or 24-hour protein quantification < 1.0 grams.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA · Santa Monica, California
- Massachusetts General Hospital · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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