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Ovarian Cancer / Pancreatic Adenocarcinoma Metastatic / Lung Cancer (NSCLC) · Phase 1/2 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record describing a planned first-in-human Phase 1/2 study of XNW27011, an antibody-drug conjugate targeting Claudin 18.2 in advanced solid tumors. No efficacy or safety results have been reported; the record documents the study design and planned enrollment only.
Phase 1/2, Interventional, Non Randomized, Parallel, Single masking, Treatment purpose. Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic, Biliary Tract Cancer, Gastric Carcinoma, Gastroesophag…; age from 18 Years. Intervention: Phase I Dose Escalation; Phase II: Expanded cohorts. n = 240. 1 site: China.
This is a clinical trial registry record describing a planned first-in-human Phase 1/2 study of XNW27011, an antibody-drug conjugate targeting Claudin 18.2 in advanced solid tumors. No efficacy or safety results have been reported; the record documents the study design and planned enrollment only.
Effect sizes, response rates, safety data, and dose recommendations are not yet available.
No clinical impact can be assessed from this registry record, as no results are reported. Clinicians should await completion and publication of Phase 1 and Phase 2 findings before drawing any conclusions about efficacy, safety, or recommended dosing of XNW27011.
This is a first-in-human Phase 1/2 trial registration with no results reported; the study is active but not yet recruiting and endpoints are not yet measured.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no results are reported. Clinicians should await completion and publication of Phase 1 and Phase 2 findings before drawing any conclusions about efficacy, safety, or recommended dosing of XNW27011.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06792435). This is a study registration, not published results. Lead sponsor: Astellas Pharma Global Development, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 240 participants (ESTIMATED). Conditions: Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic, Biliary Tract Cancer, Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma. Interventions: DRUG: XNW27011; DRUG: XNW27011. Primary outcome measures: Phase I (Dose Escalation):To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of XNW27011 , Baseline up to approximately 2 years; Phase Ⅱ (Dose Expansion):To evaluate the objective response rate (ORR) of XNW27011 by cohorts at RP2D. The objective response includes the complete response (CR) and the partial response (PR). , Baseline up to approximately 2 years. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.