ASP546C / Evopoint, Astellas - LARVOL DELTA

Phase 1b/2 study of ASP546C, a Claudin 18.2-targeting antibody-drug conjugate with a topoisomerase 1 inhibitor payload, in patients with Claudin 18.2-expressing unresectable locally advanced or metastatic solid tumors (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • CLDN18

Phase I study of XNW27011, a novel claudin 18.2 ADC, in patients with locally advanced and/or metastatic solid tumors (ESMO 2024) - "Prior PD-1 immunotherapy, irinotecan or CLDN18.2 antibody therapy seemed not to impact efficacy. XNW27011 demonstrated a favorable safety profile with large therapeutic window, superior preliminary efficacy across tumor type and CLDN 18.2 expression level, and excellent PK properties including low payload plasma exposure. The study is ongoing with the expansion phase being initiated in multiple tumor cohorts."

Clinical • IO biomarker • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CLDN18

XNW27011, a Claudin 18.2(CLDN18.2) targeted antibody-drug conjugate (ADC), in patients with CLDN18.2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJA): A phase 2 study. (ASCO 2026) - P1/2 | "XNW27011 demonstrated promising anti-tumor activity and a manageable safety profile in CLDN18.2-positive G/GEJA. A pivotal phase 3 study evaluating XNW27011 as a ≥3 line therapy in G/GEJA pts is currently ongoing."

ADC • Clinical • IO biomarker • P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Oncology • Solid Tumor • CLDN18

Efficacy and safety of XNW27011, a Claudin-18.2 targeted (CLDN18.2) ADC, in advanced pancreatic ductal adenocarcinoma: A phase 2 study. (ASCO 2026) - P1/2 | "XNW27011 showed a manageable safety profile and encouraging survival outcome in pts with PDAC expressing CLDN 18.2, supporting its further clinical development as a promising therapeutic option for patients with PDAC expressing CLDN 18.2."

ADC • Clinical • Metastases • P2 data • Oncology • Pancreatic Ductal Adenocarcinoma • CLDN18

XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies. (clinicaltrials.gov) - P1/2 | N=240 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Dec 2026

Enrollment closed • First-in-human • Trial completion date • Trial primary completion date • Biliary Cancer • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Comparison of CLDN18/CLDN18.2 IHC assays (43-14A vs EPR19202) and the correlation with clinical efficacy in patients with gastric/gastroesophageal junction adenocarcinoma treated by the novel antibody-drug conjugate XNW27011. (ASCO 2026) - P1/2 | "The IHC assays of CLDN18.2 expression with EPR19202 or CLDN18 expression with 43-14A demonstrate comparable analytical performance with high concordance. The alignment of efficacy outcomes across the two antibody-defined strata supports that CLDN18 and CLDN18.2-specific antibodies can identify patient populations with similar clinical benefit. Both antibodies can support the clinical development of XNW27011 in the treatment of patients with G/GEJ adenocarcinoma."

ADC • Clinical • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Preclinical development of XNW27011, an antibody drug conjugate targeting claudin18.2 for treatment of CLDN 18.2-positive solid tumors (AACR 2026) - "XNW27011 is expected to be a potent therapeutic ADC candidate in cancer treatment of CLDN 18.2-positive solid tumors including gastric and pancreatic adenocarcinomas. Clinical activity of XNW27011 is currently under evaluation in a Phase III clinical trial (CTR20252730)."

ADC • Preclinical • Gastric Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • CLDN18 • HER-2 • PGR

A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

New P1/2 trial • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • CLDN18 • HER-2 • PGR

XNW27011: “Preliminary efficacy in CLDN18.2+ G/GEJ adenocarcinoma”; Gastric cancer or gastroesophageal junction adenocarcinoma (Astellas) - Q1 FY2025 Results

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Efficacy and safety of XNW27011, a Claudin 18.2 targeting antibody drug conjugate with topoisomerase 1 inhibitor payload, in patients with Claudin 18.2 positive gastric/gastroesophageal junction cancer: Results from ongoing phase I/II study. (ASCO 2025) - P1/2 | "In the expansion cohorts, XNW27011 demonstrated promising anti-tumor activity and favorable safety profile in GC/GEJC pts with wide expression level of CLDN18.2. The results support further development of XNW27011 in CLDN18.2+ GC/GEJC."

Clinical • P1/2 data • Anemia • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • CLDN18

Astellas Enters Exclusive License Agreement with Evopoint Biosciences for XNW27011, a Novel Clinical-stage Antibody-Drug Conjugate Targeting CLDN18.2 (Astellas Press Release) - "The agreement grants Astellas a worldwide (excluding China's mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011...Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved."

Licensing / partnership • Gastric Cancer • Gastroesophageal Cancer • Pancreatic Cancer

XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies. (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: Evopoint Biosciences Inc.

New P1/2 trial • Biliary Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor