OncoMatch/Clinical Trials/NCT06364410
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
Is NCT06364410 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Trastuzumab Deruxtecan and Azenosertib for clinical stage iii gastric cancer ajcc v8.
Treatment: Azenosertib · Trastuzumab Deruxtecan — This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 1+, 2+, or 3+)
HER2 expression by immunohistochemistry (IHC) (1+, 2+, or 3+)
Required: HER2 (ERBB2) amplification
HER2 amplification by in situ hybridization (ISH) or next generation sequencing (NGS)
Disease stage
Required: Stage III, IV (AJCC v8)
locally advanced, unresectable, or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: trastuzumab-based treatment (trastuzumab) — if eligible for such treatment (dose expansion only)
Received prior trastuzumab-based treatment, if eligible for such treatment
Cannot have received: WEE1 inhibitor
Patients with prior treatment with a WEE1 inhibitor (dose escalation and dose expansion)
Cannot have received: topoisomerase inhibitor (trastuzumab deruxtecan, DS-8201a)
Patients with prior treatment with T-DXd (DS-8201a) or other topoisomerase inhibitors (dose escalation and dose expansion)
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L; Hemoglobin > 9.0 g/dL; Platelets ≥ 100 × 10^9/L
Kidney function
Measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min (CrCl or GFR ≥ 60 mL/min for patients with creatinine > 1.5x ULN)
Liver function
Total bilirubin ≤ 1.5 institutional ULN (Gilbert syndrome allowed if ≤ 3x ULN); AST/ALT ≤ 3x ULN (≤ 5x ULN with liver metastases)
Cardiac function
LVEF ≥ 50% by ECHO or MUGA within 28 days before enrollment
Absolute neutrophil count ≥ 1.5 × 10^9/L ... Hemoglobin > 9.0 g/dL ... Platelets ≥ 100 × 10^9/L ... Total bilirubin ≤ 1.5 institutional ULN ... AST/ALT ≤ 3 × institutional ULN ... CrCl ≥ 60 mL/min ... LVEF ≥ 50% by ECHO or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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