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Monoclonal Antibodies

Group A: AMG 355 monotherapy for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group Performance status 0 or 1

Age ≥ 18 years at the time of signing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial aims to test the safety and side effects of a drug called AMG 355 alone and in combination with pembrolizumab in people with advanced solid tumors. It also seeks to find

Who is the study for?

This trial is for adults over 18 with advanced solid tumors, including specific types like NSCLC, CRC, GC, and melanoma. Participants should be relatively healthy (performance status 0 or 1), have a life expectancy of more than three months, and at least one measurable tumor lesion. A fresh biopsy before joining the study is preferred.Check my eligibility

What is being tested?

The trial tests AMG 355 alone and combined with Pembrolizumab to find safe dosages for people with advanced solid tumors. It aims to determine the safest highest dose possible (maximum tolerated dose) and an effective phase 2 dose.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fatigue, skin issues, inflammation in various organs like lungs or intestines; infusion-related reactions are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have at least one tumor that can be measured but hasn't been biopsied for this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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 Experience a Dose Limiting Toxicity (DLT)

Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Number of Participants Who Experience a Treatment-related AE

Secondary outcome measures

Area Under the Concentration-time Curve (AUC) of AMG 355

Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples

Clinical Benefit per RECIST v1.1

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: AMG 355 and pembrolizumabExperimental Treatment2 Interventions

Specified dose on specified days

Group II: Group A: AMG 355 monotherapyExperimental Treatment1 Intervention

Specified dose on specified days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,377,703 Total Patients Enrolled

MDStudy DirectorAmgen

915 Previous Clinical Trials

924,215 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 are the eligibility criteria for individuals seeking to participate in this clinical study?

"Patients with solid tumors aged between 18 and 100 years old are sought for participation in this trial, aiming to recruit a total of 515 individuals."

Answered by AI

Does this study have an age restriction for potential participants older than half a century?

"Enrollment for this investigation is open to individuals aged 18 and older, up to but not exceeding a centenarian age."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Data from clinicaltrials.gov indicates that this particular research endeavor is not currently seeking volunteers. This trial was initially listed on March 4th, 2024 and its most recent update was on February 15th, 2024. Despite the closure of recruitment for this study, there are a substantial number of other trials, specifically 2692 studies, actively accepting participants at present."

Answered by AI

What are the potential risks associated with treatment involving Group A: AMG 355 administered as a standalone therapy for patients?

"Our research team at Power has rated the safety of Group A: AMG 355 monotherapy as a 1 on our scale. This rating is attributed to the Phase 1 status of the trial, indicating a scarcity in both safety and efficacy data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

2024. "A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06131398.

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