Your session is about to expire
← Back to Search
Monoclonal Antibodies
AMG 355 + Pembrolizumab for Advanced 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
Must not have
Chronic intake of systemic corticosteroids (eg prednisone > 10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Select...
I have at least one tumor that can be measured but hasn't been biopsied for this study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken high doses of steroids or immunosuppressants in the last week.
Select...
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Select...
I stopped a cancer treatment due to side effects from immune therapy.
Select...
I have had an organ transplant.
Select...
I have or had lung inflammation that needed steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~3130
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,466 Previous Clinical Trials
1,400,924 Total Patients Enrolled
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
944,725 Total Patients Enrolled