OncoMatch/Clinical Trials/NCT06487221
Avutometinib and Defactinib in Diffuse Gastric Cancer
Is NCT06487221 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Avutometinib and Defactinib for gastric cancer.
Treatment: Avutometinib · Defactinib — The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Allowed: CDH1 pathogenic mutation
Allowed: RHOA pathogenic mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — unresectable/metastatic
Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine.
Must have received: fluoropyrimidine — unresectable/metastatic
Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine.
Cannot have received: direct and specific inhibitor of FAK
History of treatment with a direct and specific inhibitor of FAK, MEK, or KRAS.
Cannot have received: direct and specific inhibitor of MEK
History of treatment with a direct and specific inhibitor of FAK, MEK, or KRAS.
Cannot have received: direct and specific inhibitor of KRAS
History of treatment with a direct and specific inhibitor of FAK, MEK, or KRAS.
Lab requirements
Blood counts
hemoglobin ≥ 9.0 g/dL (≥ 8.5 g/dL if no significant cardiovascular risk); platelets ≥ 100,000/mm3; ANC ≥ 1500/mm3
Kidney function
creatinine clearance rate of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula
Liver function
total bilirubin ≤ 1.5 × ULN (Gilbert syndrome < 3.0 mg/dL); ALT and AST ≤ 2.5 × ULN (or < 5 x ULN in patients with liver metastases)
Cardiac function
left ventricular ejection fraction ≥ 55% by ECHO or MUGA; baseline QTc interval < 460 ms for females and ≤ 450 ms for males (average of triplicate readings) using Fredericia's QT correction formula; INR ≤ 1.5 and PTT ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation; albumin ≥ 3.0 g/dL; CPK ≤ 2.5 x ULN
Adequate organ function, defined by the following laboratory parameters: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center · New York, New York
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