ASP2138 / Xencor, Astellas - LARVOL DELTA

ASP2138 Monotherapy or in Combination With Pembrolizumab and mFOLFOX6 or With Ramucirumab and Paclitaxel in Claudin 18 Isoform 2 (CLDN18.2)+ Locally Advanced (LA) Unresectable or Metastatic Gastric or Gastroesophageal Junction (mG/GEJ) Adenocarcinoma: Phase 1/1b Trial (ESMO 2025) - No abstract available

Combination therapy • Metastases • Monotherapy • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CLDN18

ASP2138 Monotherapy in Patients (Pts) With Claudin 18 Isoform 2 (CLDN18.2)+, Advanced Solid Tumors: Phase 1/1b Trial (ESMO 2025) - No abstract available

Clinical • Metastases • Monotherapy • P1 data • Oncology • Solid Tumor • CLDN18

A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

Monotherapy • New P1 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer (clinicaltrials.gov) - P1 | N=305 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2026 ➔ Apr 2027 | Trial primary completion date: Jun 2026 ➔ Oct 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer (clinicaltrials.gov) - P1 | N=305 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Jun 2026 ➔ Dec 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Clinical trials of CD3/CLDN18.2 dual antibodies launched in China; latest data on IBI389 for the treatment of pancreatic cancer and gastric cancer released [Google translation] (new.qq.com) - "On May 30, according to the CDE clinical trial registration and information disclosure platform, Astellas' CD3/CLDN18.2 dual antibody ASP2138 launched a Phase I/Ib study in China, aiming to evaluate the efficacy and safety in patients with metastatic or locally advanced unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma or metastatic pancreatic adenocarcinoma expressing CLDN 18.2 (registration number: CTR20241945)....However the study was registered and launched on ClinicalTrials.gov in May 2022 (registration number: NCT05365581), with a plan to enroll 275 people worldwide, and the first subject was enrolled in June 2022. This time, the domestic part was launched."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of ASP2138 in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, Pancreatic Cancer (clinicaltrials.gov) - P1 | N=275 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

ASP2138, a novel 2+1 format, claudin 18.2 x CD3 bispecific antibody, demonstrates selectivity and activity in preclinical cancer models (AACR 2023) - P1 | "ASP2138 exhibited an antitumor effect on human CLDN18.2-expressing gastric cancer in a human PBMC-engrafted NOG mouse model in vivo. In summary, ASP2138 is expected to show a clinical effect through cytotoxicity against CLDN18.2-expressing tumor cells by T-cell activation that results from selective binding to CLDN18.2 and CD3."

IO biomarker • Preclinical • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18 • IFNG

A Study of ASP2138 in Adults With Stomach Cancer or Pancreatic Cancer (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9 • CLDN18 • PD-L1

A Study of ASP2138 in Adults With Stomach Cancer or Pancreatic Cancer (clinicaltrials.gov) - P1 | N=240 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

IO biomarker • New P1 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9 • CLDN18 • PD-L1