OncoMatch/Clinical Trials/NCT07070466
Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
Is NCT07070466 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Disease stage
Required: Stage IV
Patients may not have received prior therapy for Stage IV disease.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for Stage IV disease
Exception: prior adjuvant therapy allowed if >6 months since completion
Patients may not have received prior therapy for Stage IV disease. Patients may have received prior adjuvant therapy if more than 6 months have elapsed between the end of adjuvant therapy and registration.
Cannot have received: PD-1 or PD-L1 inhibitor
Exception: allowed if completed >6 months prior 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 ≤ 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 →Frequently asked questions
Is NCT07070466 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for Stage IV disease, PD-1 or PD-L1 inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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