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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

Study Summary

This trial is testing a new drug to see if it is safe and tolerated by adults, and to find the highest dose that is still safe.

Eligible Conditions

MUC17-positive Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Dose-limiting toxicities (DLT)

Incidence of Treatment-emergent adverse events (TEAEs)

Incidence of Treatment-related adverse events (TRAEs)

+3 more

Secondary outcome measures

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.

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Who is running the clinical trial?

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,630 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

924,073 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current regulatory standing of AMG 199?

"AMG 199's safety is still being determined, and it was thusly assigned a score of 1. This early phase clinical trial has collected limited data on both efficacy and security."

Answered by AI

Is it feasible for me to participate in this research?

"This clinical experiment is recruiting 240 individuals with muc17-positive solid tumours aged between 18 and 99. Notably, applicants should satisfy the following criteria: Subjects affected by metastatic or locally advanced inoperable gastric adenocarcinoma/GEJ adenocarcinoma positive for MUC17 who are unresponsive to standard systemic therapies including a platinum, fluoropyrimidine, nivolumab (used alongside a platinum and fluoropyrimidine), taxane or irinotecan plus an approved VEGFR antibody/TKI; subjects enduring unresectable metastatic colorectal cancer that"

Answered by AI

What is the main purpose of this clinical trial?

"This clinical trial has a three year time frame during which its success will be judged on the basis of Dose-limiting toxicities (DLT). Additionally, other factors such as Overall survival (OS), Objective response (OR) and Minimum serum concentration (Cmin) are also being monitored to assess AMG 199's preliminary anti-tumor activity and pharmacokinetic profile."

Answered by AI

Does this research protocol allow for individuals over the age of sixty to participate?

"To be eligible for this medical trial, patients must between 18 and 99 years of age. Currently there are 11 studies dedicated to minors and 575 specifically focused on seniors."

Answered by AI

Is there still room for participants in this medical experiment?

"Confirmation from clinicaltrials.gov reveal that this trial is currently recruiting participants; the initial post was made on January 20th 2020 and the information has been updated as recently as November 30th 2022."

Answered by AI

What is the current enrollment of participants in this clinical trial?

"Affirmative. The information available on clinicaltrials.gov shows that this research study is currently open for recruitment, having been posted initially on January 20th 2020 and most recently edited November 30th 2022. 240 patients are required across 4 sites to take part in the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

2020. "Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04117958.