NL-OMON56431
Completed
Not Applicable
A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers - 20180290
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cancer of stomach
- Sponsor
- Amgen
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •103 \- Subjects with histologically or cytologically confirmed metastatic or
- •locally advanced gastric adenocarcinoma or GEJ adenocarcinoma positive for
- •MUC17 as defined by the test described herein. Subjects should have been
- •refractory to or have relapsed after two or more prior lines of standard
- •systemic therapy that included a platinum, a fluoropyrimidine, nivolumab (in
- •combination with a platinum and a fluoropyrimidine), either a taxane or
- •irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR)
- •antibody/tyrosine kinase inhibitor (TKI).
- •OR Subjects with histologically or cytologically confirmed metastatic or
- •locally advanced unresectable CRC positive for MUC17 as defined by the test
Exclusion Criteria
- •Any anticancer therapy or immunotherapy within 4 weeks of start of first dose.
- •Central nervous system (CNS) metastases, leptomeningeal, or spinal cord
- •compression.
- •Autoimmune disorders requiring chronic systemic steroid therapy or any other
- •form of immunosuppressive therapy. Subjects may be included if the treatment
- •is discontinued more than 3 months prior to the first dose of AMG 199, there is
- •a low likelihood of relapse from the autoimmune disorder, AND there is
- •agreement between the investigator and the Amgen Medical Monitor.
- •Refer to 5\.2 of the protocol.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignanciesbeenmergstoornis: MDS (myelodysplastisch syndroom/myelodysplasie)Acute myeloid leukemiacancer of the bloodmyelodysplastic Syndrome10024324NL-OMON55859Amgen10
Completed
Not Applicable
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG (PN-1007) in anti-MAG neuropathy patients.anti-MAG neuropathyauto-immune10012303NL-OMON49059Polyneuron Pharmaceuticals AG9
Completed
Phase 2
A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta ThalassemiaBeta Thalassemiainherited blood disorder10038158NL-OMON54921IMARA, Inc.15
Completed
Phase 2
A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndromeNL-OMON48225Millendo Therapeutics SAS23
Completed
Phase 2
A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphomanon-Hodgkin Peripheral T-cell lymfomenHodgkin and non-Hodgkin lymphomaleukemia1002531910025320NL-OMON48105Sanofi-aventis7