OncoMatch/Clinical Trials/NCT06792435
XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.
Is NCT06792435 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including XNW27011 and XNW27011 for pancreatic adenocarcinoma metastatic.
Treatment: XNW27011 · XNW27011 — This is a global, multi-center, open-label, Phase I/II first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and/or metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and/or metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Ovarian Cancer
Colorectal Cancer
Cholangiocarcinoma
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: CLDN18 expression
Only patients with tumor expressing CLDN 18.2 will be enrolled. The most recently available tumor samples of patients will be examined by IHC at a central laboratory.
Disease stage
Metastatic disease required
locally advanced or metastatic solid tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
which has failed on standard therapy or is intolerable to available standard therapy, or there is no available standard therapy for the tumor
Cannot have received: ADC targeting CLDN18.2
Patients who have previously been treated with ADCs or CAR-T targeting CLDN18.2
Cannot have received: CAR-T targeting CLDN18.2
Patients who have previously been treated with ADCs or CAR-T targeting CLDN18.2
Cannot have received: monoclonal antibody
Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies
Cannot have received: Topoisomerase I inhibitor or Topoisomerase inhibitor-based ADC (Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan)
Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0 g/dL
Kidney function
Creatinine clearance (Ccr) ≥60 mL/min (Phase I), ≥50 mL/min (Phase II) as calculated using the modified Cockcroft-Gault equation
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 1.5 × ULN (if liver metastases are present, ≤ 3 × ULN)
Cardiac function
QTc prolongation to ≤480 ms (Fridericia's Correction Formula, average of 3 ECGs); LVEF ≥ 50% by echocardiography
Adequate organ function, evidenced by the following laboratory results: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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