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vepsitamab (AMG 199)
i
Other names: AMG 199, AMG199, AMG-199
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Company:
Amgen, BeOne Medicines
Drug class:
CD3 agonist, MUC17 inhibitor
Related drugs:
8ms
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.
Journal • IO biomarker
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MUC17 (Mucin 17)
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vepsitamab (AMG 199)
over2years
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, Amgen | N=240 --> 58 | Active, not recruiting --> Terminated; Business decision
Enrollment change • Trial termination
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • MUC17 (Mucin 17)
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BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
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vepsitamab (AMG 199)
almost3years
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, 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
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
|
vepsitamab (AMG 199)
3years
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, Amgen | Trial completion date: Oct 2025 --> Dec 2026 | Trial primary completion date: Mar 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
|
vepsitamab (AMG 199)
3years
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, 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
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
|
vepsitamab (AMG 199)
3years
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, Amgen | Trial completion date: Apr 2025 --> Dec 2026 | Trial primary completion date: Sep 2023 --> Jun 2025
Trial completion date • Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
|
vepsitamab (AMG 199)
almost4years
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, Amgen | Trial primary completion date: Apr 2025 --> Aug 2023
Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
|
vepsitamab (AMG 199)
4years
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, Amgen | Trial completion date: Nov 2025 --> Apr 2025 | Trial primary completion date: Nov 2025 --> Apr 2025
Clinical • Trial completion date • Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type
|
vepsitamab (AMG 199)
4years
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, 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
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
|
BRAF V600E • MSI-H/dMMR • BRAF V600
|
vepsitamab (AMG 199)
over5years
[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)
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
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HER-2 (Human epidermal growth factor receptor 2)
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irinotecan • vepsitamab (AMG 199)
almost6years
[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)
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
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HER-2 (Human epidermal growth factor receptor 2)
|
irinotecan • vepsitamab (AMG 199)
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