Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

To evaluate the safety and tolerability of AMG 199 in adult subjects with MUC17-positive gastric and gastroesophageal junction cancer and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Official Title

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 Gastric and Gastroesophageal Junction Cancer

Details

AMG 199 is a novel half-life extended (HLE) bispecific T cell engager (BiTE®) molecule designed to direct T cells towards MUC17-expressing cells. This is a first-in-human study in adult subjects with MUC17-positive gastric cancer or gastroesophageal junction (GEJ) cancer, to assess AMG 199 safety, tolerability, pharmacokinetics (PK), and anti-tumor activity, with additional exploratory objectives to assess pharmacodynamics (PD), correlative biomarker analysis, and immunogenicity. The primary end point is to evaluate the safety and tolerability of AMG 199 in adult subjects, and determine the MTD and RP2D. The secondary end point is characterize the PK and anti-tumor activity of AMG 199.

Keywords

Gastric and Gastroesophageal Junction Cancer AMG 199

Eligibility

You can join if…

Open to people ages 18-99

Key Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma positive for MUC17. Subjects should not be eligible for curative surgery and should have been refractory to or have relapsed after two or more prior lines of standard systemic therapy that included a platinum, a fluoropyrimidine, either a taxane or irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR) antibody/tyrosine kinase inhibitor (TKI).
  • For 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.
  • Subjects may also be included if the aforementioned therapeutic options were medically not appropriate for them. In these cases, the reason(s) why required prior therapies for gastric cancer were medically not appropriate should be documented in the subject's electronic case report form (eCRF).
  • 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.

You CAN'T join if...

Key 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.

Locations

  • University of California at Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
ID
NCT04117958
Phase
Phase 1
Study Type
Interventional
Last Updated