vepsitamab (AMG 199) / Amgen, BeOne Medicines - LARVOL DELTA

Construction of Bispecific T-Cell Engager Radiotracer and Its Micro-PET Evaluation in Pancreatic Cancer. (PubMed, Mol Pharm) - "In summary, the 89Zr-M17C3 radiotracer exhibited high affinity for MUC17 and CD3 and successfully differentiated MUC17-positive tumors from MUC17-negative tumors while simultaneously providing insight into the T-cell distribution. This study highlights the potential of 89Zr-M17C3 as a versatile imaging tool to support patient stratification and therapeutic monitoring in tumor-targeted immunotherapy, particularly for bispecific T-cell engager-based approaches such as AMG199."

IO biomarker • Journal • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • MUC17

Immuno-Analytics of Patients with Gastric Cancer: Impact of Systemic Polychemotherapy on Peripheral T-Cell Fitness and Immunologic Features of Gastric Cancer Tissue (ITOC 2024) - "A novel bispecific antibody directed against Mucin 17 was developed and is currently being tested in an early first in human clinical trial (AMG 199)...Results Polychemotherapy consisting of 5-FU, docetaxel and oxaliplatin led to an increase in CD8 + T cells and a shift towards memory T cells, whereas the proportion of Tregs was stable...Hence, our data encourage the concept of sequencing bispecifics in a short time interval after completion of polychemotherapy. Further immunomonitoring is crucial for validating and advancing this combination approach."

Clinical • IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor • CD276 • CD8 • HAVCR2 • IL2RA • LAG3 • MUC17

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1 | N=58 | Terminated | Sponsor: Amgen | N=240 ➔ 58 | Active, not recruiting ➔ Terminated; Business decision

Enrollment change • Trial termination • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • BRAF • KRAS • MSI • MUC17 • NRAS

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1 | N=240 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2027 ➔ May 2023 | Trial primary completion date: Aug 2025 ➔ May 2023

Enrollment closed • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • BRAF • KRAS • MSI • NRAS

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: Amgen | Trial completion date: Oct 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • MSI • NRAS

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: Amgen | N=165 ➔ 240 | Trial completion date: Dec 2026 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Mar 2024

Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • MSI • NRAS

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1 | N=165 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • MSI • NRAS

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1; N=165; Recruiting; Sponsor: Amgen; Trial primary completion date: Apr 2025 ➔ Aug 2023

Clinical • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • MSI • NRAS

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1; N=150; Recruiting; Sponsor: Amgen; Trial completion date: Nov 2025 ➔ Apr 2025; Trial primary completion date: Nov 2025 ➔ Apr 2025

Clinical • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • MSI • NRAS

[VIRTUAL] A phase 1 study of AMG 199, a half-life extended bispecific T-cell engager (HLE BiTE®) immune therapy, targeting MUC17 in patients with gastric and gastroesophageal junction cancer (ESMO-GI 2020) - P1 | "Key eligibility criteria include metastatic or locally advanced unresectable MUC17-positive (as determined by IHC using a central laboratory assay) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma ineligible for curative surgery and relapsed or treatment-refractory following ≥2 lines including a platinum, a fluoropyrimidine, taxane or irinotecan, and an approved vascular endothelial growth factor receptor antibody or tyrosine kinase inhibitor. Legal entity responsible for the study Amgen, Inc. Funding Amgen, Inc."

Clinical • P1 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER-2

[VIRTUAL] Trial in progress: A phase I study of AMG 199, a half-life extended bispecific T-cell engager (HLE BiTE) immune therapy, targeting MUC17 in patients with gastric and gastroesophageal junction (G/GEJ) cancer. (ASCO 2020) - P1 | "Key eligibility criteria include metastatic or locally advanced unresectable MUC17-positive (as determined by IHC using a central laboratory assay) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma ineligible for curative surgery and relapsed or treatment-refractory following ≥2 lines including a platinum, a fluoropyrimidine, taxane or irinotecan, and an approved vascular endothelial growth factor receptor antibody or tyrosine kinase inhibitor. For more information, please contact Amgen Medical Information: medinfo@amgen.com. Research Funding: Amgen"

Clinical • P1 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers (clinicaltrials.gov) - P1; N=150; Recruiting; Sponsor: Amgen; N=70 ➔ 150; Trial completion date: Jun 2025 ➔ Nov 2025; Trial primary completion date: Jun 2025 ➔ Nov 2025

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • MSI • NRAS

Amgen Reports First Quarter 2021 Financial Results (PRNewswire) - "The following programs continue to enroll patients in dose escalation studies: (i) BiTE® molecules AMG 330 and AMG 427, targeting CD33 and fms-like tyrosine kinase 3 (FLT3), respectively, for acute myeloid leukemia; (ii) AMG 176, a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) for hematologic malignancies; (iii) HLE BiTE molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 (CLDN18.2), respectively, for gastric and gastroesophageal junction cancer; (iv) AMG 509, a bivalent T-cell engager XmAb® 2+1 antibody targeting six transmembrane epithelial antigen of the prostate 1 (STEAP1) for prostate cancer. AMG 256, a bifunctional interleukin-21 agonist for PD-1 positive solid tumors."

Enrollment status • Acute Myelogenous Leukemia • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

Study of AMG 199 in Subjects With MUC17-Positive Gastric and Gastroesophageal Junction Cancer (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Trial completion date: Mar 2024 ➔ Jun 2025; Trial primary completion date: Sep 2022 ➔ Jun 2025

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] Preclinical evaluation of BiTE®immune therapy targeting MUC17 or CLDN18.2 for gastric cancer (AACR-II 2020) - "In contrast, treatment with AMG 910 led to direct cell killing of CLDN18.2-expressing gastric mucosal cells in NHP, a finding which was fully reversible once treatment was stopped. AMG 199 and AMG 910 may offer the potential to improve outcomes in advanced gastric patients worldwide."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 199 in Subjects With MUC17-Positive Gastric and Gastroesophageal Junction Cancer (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Trial completion date: Sep 2026 ➔ Mar 2024; Trial primary completion date: Mar 2024 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 199 in Subjects With MUC17-Positive Gastric and Gastroesophageal Junction Cancer (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2023 ➔ Sep 2026; Trial primary completion date: Jul 2022 ➔ Feb 2024

Clinical • Enrollment open • Trial completion date • Trial primary completion date • HER-2

Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 199 in Subjects With MUC17-Positive Gastric and Gastroesophageal Junction Cancer (clinicaltrials.gov) - P1; N=70; Not yet recruiting; Sponsor: Amgen; Trial completion date: Sep 2023 ➔ Dec 2023; Initiation date: Dec 2020 ➔ Dec 2019; Trial primary completion date: Mar 2022 ➔ Jul 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date