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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 48 months
Awards & highlights
Study Summary
This trial is testing a new drug that could help treat cancer by blocking a protein that stops the immune system from attacking tumors.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subject incidence of Dose limiting toxicities (DLTs)
Subject incidence of changes in vital signs
Subject incidence of clinical laboratory tests
+2 moreSecondary outcome measures
Area under the serum concentration-time curve (AUC) of AMG 404
Disease control rate (DCR)
Duration of overall response
+6 moreSide effects data
From 2023 Phase 1 trial • 17 Patients • NCT0452445550%
Pyrexia
38%
Constipation
38%
Cytokine release syndrome
38%
Hypokalaemia
25%
Neutropenia
25%
Sinus tachycardia
25%
Myalgia
25%
Tremor
25%
Erythema
25%
Abdominal pain
25%
Contusion
25%
Vascular device infection
25%
Rash
25%
Stomatitis
25%
Diarrhoea
25%
Asthenia
13%
Urosepsis
13%
Cognitive disorder
13%
Seizure
13%
Acute kidney injury
13%
Colitis
13%
Nausea
13%
Non-cardiac chest pain
13%
Upper respiratory tract infection
13%
Decreased appetite
13%
Hypomagnesaemia
13%
Arthralgia
13%
Intervertebral disc disorder
13%
Dizziness
13%
Hypoaesthesia
13%
Anuria
13%
Epistaxis
13%
Hiccups
13%
Hypoxia
13%
Respiratory failure
13%
Encephalopathy
13%
Febrile neutropenia
13%
Condition aggravated
13%
Arrhythmia
13%
Asymptomatic bacteriuria
13%
Cytomegalovirus infection
13%
Weight decreased
13%
Hyperglycaemia
13%
Tachypnoea
13%
Skin disorder
13%
Immune effector cell-associated neurotoxicity syndrome
13%
Blood alkaline phosphatase increased
13%
Blood lactic acid increased
13%
Presyncope
13%
Rash erythematous
13%
Rash pruritic
13%
Hypotension
13%
Haematuria
13%
Cardiac arrest
13%
Leukocytosis
13%
Musculoskeletal chest pain
13%
Sepsis
13%
Gastrooesophageal reflux disease
13%
Conjunctivitis
13%
Anxiety
13%
Generalised oedema
13%
Hepatic enzyme increased
13%
Neutropenic colitis
13%
Cellulitis
13%
Gamma-glutamyltransferase increased
13%
Hyponatraemia
13%
Peripheral sensory neuropathy
13%
Hyperbilirubinaemia
13%
Hypophosphataemia
13%
Muscular weakness
13%
Headache
13%
Insomnia
13%
Oropharyngeal oedema
13%
Hypercalcaemia
13%
COVID-19
13%
Lower respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2a: Blinatumomab + AMG 404 (480 mg)
Cohort 1: Blinatumomab + AMG 404 (240 mg)
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 9Experimental Treatment1 Intervention
Cohort 9
Group II: Cohort 8Experimental Treatment1 Intervention
Cohort 8
Group III: Cohort 7Experimental Treatment1 Intervention
Cohort 7
Group IV: Cohort 6Experimental Treatment1 Intervention
Cohort 6
Group V: Cohort 4Experimental Treatment1 Intervention
Cohort 4
Group VI: Cohort 3Experimental Treatment1 Intervention
Cohort 3
Group VII: Cohort 2Experimental Treatment1 Intervention
Cohort 2
Group VIII: Cohort 1Experimental Treatment1 Intervention
Cohort 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 404
2020
Completed Phase 1
~230
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,517 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,960 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a live vaccine within the past 4 weeks before starting the study drug.You have a brain tumor that has not been treated or is causing symptoms.You have had severe allergic reactions or bad reactions to antibody treatments in the past.You have or had any autoimmune disease or immune system problems, except for certain conditions like Type I diabetes, vitiligo, psoriasis, and thyroid issues that don't need immunosuppressive treatment.You have had a type of inflammation in your colon called immune-related colitis in the past. However, if you have had an infection-related colitis and it has been treated properly and you have fully recovered, you may still be able to participate in the study as long as at least 3 months have passed since the diagnosis of colitis.You have received treatment with certain types of drugs that target the immune system before or at the same time as this study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 6
- Group 2: Cohort 8
- Group 3: Cohort 7
- Group 4: Cohort 9
- Group 5: Cohort 1
- Group 6: Cohort 2
- Group 7: Cohort 3
- Group 8: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Solid Tumors Patient Testimony for trial: Trial Name: NCT03853109 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial currently available to participants?
"Clinicaltrials.gov shows that this clinical trial, which was initially published on March 5th 2019 and last modified August 31st 2022, is not presently enrolling patients. However, there are 2502 other trials actively recruiting at the moment."
Answered by AI
Has the Food and Drug Administration sanctioned AMG 404 for market utilization?
"The safety profile of AMG 404 is estimated to be 1, as this study's Phase 1 designation indicates that there are only limited data regarding its efficacy and security."
Answered by AI
Am I able to join this research initiative?
"In order to be selected for this clinical trial, the participants must have a diagnosis of solid tumors or advanced solid tumors and fall within the age range between 18 and 100. This medical research project is aiming to recruit 170 volunteers total."
Answered by AI
In which facilities is this trial administered?
"As well as multiple other medical facilities, patients in this trial can be enrolled at Wake Forest University Health Sciences (Houston, TX), the University of Texas MD Anderson Cancer Center (Louisville, KY) and the University of Louisville James Graham Brown Cancer Center (Denver, CO)."
Answered by AI
Does this experiment have a designated age limit for participants?
"The minimum age for participation in this medical study is 18 and there is no upper limit, with the maximum being 100 years old."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
My fathers lung cancer.
PatientReceived no prior treatments
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