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Monoclonal Antibodies

AMG 199 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial is testing AMG 199, a new medicine that helps the immune system fight certain cancers. It targets adults with cancers that have a specific marker (MUC17). The medicine guides immune cells to attack these cancer cells.

Eligible Conditions
  • MUC17-positive Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Dose-limiting toxicities (DLT)
Incidence of Treatment-emergent adverse events (TEAEs)
Incidence of Treatment-related adverse events (TRAEs)
+3 more
Secondary study objectives
Accumulation following multiple dosing of AMG 199
Area under the concentration-time curve (AUC) of AMG 199
Duration of response (DOR).
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose-exploration phaseExperimental Treatment1 Intervention
The dose-exploration phase of the study will estimate the MTD (Maximum Tolerated Dose) of AMG 199 using a Bayesian logistic regression model (BLRM). A RP2D (Recommended Phase 2 Dose) may be identified based on emerging safety, efficacy, and PD (Pharmacodynamics) data prior to reaching an MTD. Alternative dosing schedule(s) may be explored based on emerging PK (Pharmacokinetics) and safety data.
Group II: Dose-expansion phaseExperimental Treatment1 Intervention
The dose-expansion phase will be conducted to confirm safety, PK, and PD at the MTD or RP2D and to obtain further safety and efficacy data and enable correlative biomarker analysis.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,892 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,807 Total Patients Enrolled
~10 spots leftby Sep 2025
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