Clinical trialPhase 1Terminated
Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers
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
- Outcome
- Stopped earlyBusiness decision (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 20 January 2020
- Expected end
- 1 June 2023
- Enrollment
- 58 participants
- Sites
- 21
- Primary outcomes
- Incidence of Dose-limiting toxicities (DLT); Incidence of Treatment-emergent adverse events (TEAEs); Incidence of Treatment-related adverse events (TRAEs); Number of subjects with changes in vital signs; Number of subjects with changes in clinical laboratory tests
- Sponsor
- Industry
- Results posted
- No
- Last update
- 14 October 2025
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Brief summary public domain (ClinicalTrials.gov)
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Detailed description public domain (ClinicalTrials.gov)
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 solid tumors including gastric cancer, gastroesophageal junction (GEJ), colorectal, and pancreatic cancers, collectively referred to as "solid tumors" in this clinical investigation 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.