NL-OMON56431CompletedNot 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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 10
Study Overview
Brief Summary
Trial ended prematurely
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •described herein. Subjects should have been refractory
- •to or have relapsed after at least two and up to five prior lines of standard
- •systemic therapy. Therapy should have included an approved vascular endothelial
- •growth factor (VEGF) antibody (if clinically appropriate) and epidermal growth
- •factor receptor (EGFR) antibody (if kirsten rat sarcoma
- •(KRAS)/ neuroblastoma RAS viral oncogene homolog (NRAS)/ v-Raf murine sarcoma
- •viral oncogene homolog B1 (BRAF) wild type tumor).
- •OR Subjects with histologically or cytologically confirmed unresectable or
- •metastatic pancreatic ductal adenocarcinoma positive for MUC17 as defined by
- •the test described herein. Subjects should have been refractory to or have
- •relapsed after at least one and up to three prior lines of standard systemic
- •104 - Gastric adenocarcinoma and GEJ adenocarcinoma: Subjects eligible for
- •human epidermal growth factor receptor 2 (HER2) directed therapy, prior
- •systemic therapy should have included a HER2 targeting antibody approved for
- •treatment of gastric cancer. For Subjects with microsatellite instability high
- •(MSI H) or mismatch repair deficient (dMMR) tumors a prior line of treatment
- •should have included an approved PD-1-blocking antibody.
- •105 - Subjects may also be included if the aforementioned therapeutic options
- •were medically not appropriate for them.
- •106 - For dose-expansion only: Subjects with at least one measurable lesion >=
- •10mm which has not undergone biopsy within 3 months of screening scan. This
- •lesion cannot be biopsied at any time during the study.
- •Refer to section 5.1 of the protocol.
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.
Investigators
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