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Monoclonal Antibodies

Cohort 2b: AMG 910 15 μg for Stomach Cancer

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 1 year and 2 years
Awards & highlights

Study Summary

This trial is testing a new drug, AMG 910, to see if it is safe for people to take and what the maximum dose people can tolerate.

Eligible Conditions
  • Stomach Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
Number of Participants Who Experienced a Treatment-emergent AE (TEAE)
Secondary outcome measures
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC0_168hr)
Cohort 1 Only: Accumulation Ratio (AR) of AMG 910
DOR Per iRECIST
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2b: AMG 910 15 μgExperimental Treatment1 Intervention
For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 μg. For the remainder of Cycles 1 and 2, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 μg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 μg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Group II: Cohort 1b: AMG 910 6.5 μgExperimental Treatment1 Intervention
For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 μg. For the remainder of Cycles 1 and 2, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 μg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 μg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
Group III: Cohort 1: AMG 910 6.5 μgExperimental Treatment1 Intervention
For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 μg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 μg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,367 Previous Clinical Trials
1,386,238 Total Patients Enrolled
MDStudy DirectorAmgen
910 Previous Clinical Trials
923,771 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
2020. "Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260191.
~3 spots leftby Apr 2025
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