AMG 404 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nucleo de Oncologia da Bahia, Salvador, Brazil
Solid Tumors, Advanced Solid Tumors+1 More
AMG 404 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug which blocks a protein on the surface of immune cells may help treat cancer.

See full description

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

This trial is evaluating whether AMG 404 will improve 5 primary outcomes and 9 secondary outcomes in patients with Solid Tumors, Advanced Solid Tumors. Measurement will happen over the course of 28 Days.

24 months
Area under the serum concentration-time curve (AUC) of AMG 404
Disease control rate (DCR)
Duration of overall response
Duration of stable disease
Maximum observed concentration (Cmax) of AMG 404
Objective tumor response
Progression-free survival
Subject incidence of anti-AMG 404 antibodies
Time of maximum observed concentration (Tmax) of AMG 404
28 Days
Subject incidence of Dose limiting toxicities (DLTs)
Subject incidence of changes in vital signs
Subject incidence of clinical laboratory tests
Subject incidence of treatment emergent adverse events
Subject incidence of treatment related adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

9 Treatment Groups

Cohort 5
1 of 9
Cohort 8
1 of 9
Cohort 6
1 of 9
Cohort 7
1 of 9
Cohort 9
1 of 9
Cohort 1
1 of 9
Cohort 2
1 of 9
Cohort 3
1 of 9
Cohort 4
1 of 9
Experimental Treatment

This trial requires 170 total participants across 9 different treatment groups

This trial involves 9 different treatments. AMG 404 is the primary treatment being studied. Participants will be divided into 9 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort 5
Drug
Cohort 5
Cohort 8
Drug
Cohort 8
Cohort 6
Drug
Cohort 6
Cohort 7
Drug
Cohort 7
Cohort 9
Drug
Cohort 9
Cohort 1
Drug
Cohort 1
Cohort 2
Drug
Cohort 2
Cohort 3
Drug
Cohort 3
Cohort 4
Drug
Cohort 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 404
2018
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

Wake Forest Baptist Health - Winston-Salem, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subject has provided informed consent prior to initiation of any study specific activities/procedures.
Age greater than or equal to 18 years old at the time of signing informed consent.
Life expectancy of greater than 3 months, in the opinion of the investigator Subject must have histologically or cytologically confirmed metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation.
At least 1 measurable as defined by modified RECIST 1.1 which has not undergone biopsy within 3 months of the screening scan. This lesion cannot be biopsied at any time during the study. Note: if there is only one lesion available for biopsy and radiographic assessment, it may be permitted to be biopsied after discussion with sponsor.
Subjects with treated brain metastases are eligible provided they meet the following criteria: Definitive therapy was completed at least 2 weeks prior to enrollment. No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.
Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.
Hematologic function, as follows without growth factor support within 2 weeks prior to study day 1: Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10E9/L; Platelet count greater than or equal to 75 x 10E9/L; Hemoglobin greater than or equal to 9 g/dL (90 g/L).
Adequate renal laboratory assessments, as follows: Estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation . 60 ml/min/1.73 m^2 for Cohorts 1, 2, 4 and 5.
Estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation >= 45 ml/min/1.73 m^2 for Cohorts 3, 6, 7, 8 and 9.

Patient Q&A Section

What are common treatments for cancer?

"It seems many common treatments for cancer are useless. It might have been better if the trials that support the treatments were of higher quality." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Symptoms of a malignant neoplasm may be vague and nonspecific. The most common sign of cancer is weight loss or loss of appetite. However, these two manifestations may occur in more than 90% of cases of bowel cancer. A history of cancer may increase the likelihood that a current ailment, such as gastroenteritis, will be found to be a manifestation of cancer." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"The word cancer was coined for the first time in around 1000 BC. It is also an ancient concept which has changed considerably over the last millennia. The word comes from Greek –kýmōs-, ("kingdom"), -cýma-, ("of a seed"), which comes from kýmōn, ("seed of"), and –kýma- ("birth") with the assumption of a "crush" or "foetus" (of which there is no evidence or known use to this day), and finally –kýma-, ("birth")." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"It is currently too early to be certain that cancer can be cured although it seems that some patients are responding to treatment. This is because there are some patients who may not respond to any treatment but also patients whose response to treatments may be transient. These patients are still at risk of relapse. The current challenge will be to identify these patients and to devise the best treatments or combination treatments to deal with them. However, we also need to think how and when to treat these 'transient responder' patients if we do eventually find a way to cure them. This paper highlights many questions to consider and provides some suggestions." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Each year, around 8.8 million US adults are diagnosed with some form of cancer. This makes up 20.6% of American adults. Overall, there are about 2.8 people per 1000 persons diagnosed with cancer in the United States each year. \n" - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Many types of cancer are multifactorial and many causal pathways connect environmental and genetic factors with the underlying biological cause. It is now considered more important to understand the role of environmental factors that are modifiable, rather than the underlying biological pathways. Cancer prevention is an urgent matter that needs to be explored beyond identifying environmental factors that are amenable to intervention." - Anonymous Online Contributor

Unverified Answer

Is amg 404 typically used in combination with any other treatments?

"Amg 404 was typically used in combination with any of the following chemotherapy regimens: gemcitabine, paclitaxel, docetaxel, liposomal doxorubicin, doxorubicin, vincristine, and cisplatin/paclitaxel. We do not consider the combination of Amg 404 and gemcitabine plus paclitaxel to be effective. The combination of Amg 404 with gemcitabine warrants further study. In a recent study, findings suggest that Amg 404 may be an active agent when used in a combination treatment regimen." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of amg 404?

"In this small study there were no common or clinically meaningful differences between placebo and Amg 404 in the incidence of side effects assessed by patients or physicians. The most common treatment-emergent adverse events in patients in the placebo arm included headache, headache worsened or new, headache worsened upon standing, and fatigue. The most common treatment-emergent adverse events in physicians in the placebo arm included headache, headache worsened or new, headache worsened upon standing, and diarrhea. The most common treatment-emergent adverse events in patients treated with Amg 404 included headache, headache worsened or new, headache worsened upon standing, nausea, constipation, and fatigue." - Anonymous Online Contributor

Unverified Answer

What does amg 404 usually treat?

"Based on the results to date, AMG-404 has been shown to produce durable antitumor responses at a high therapeutic dose. Although there have been ongoing Phase II clinical trials, the current clinical development plan for AMG-404 is focused on evaluating long-term efficacy in conjunction with conventional chemotherapies and radiation therapy, with the goal of developing a novel regimen for patients requiring systemic therapy." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"The incidence of cancer is not different in firstborn versus secondborn siblings in a population of 5- to 10-year-old boys, and cancer incidence as a total number of cancer cases or in specific sites is not different in firstborn versus secondborn boys. This suggests that a predominant oncogene is not involved in hereditary cancer predisposition in all children, though one or more are likely to be involved in some families." - Anonymous Online Contributor

Unverified Answer

Is amg 404 safe for people?

"It was well tolerated by patients. The side effects encountered were mild in nature. Amg 404 is a newly developed drug with a potential therapeutic role in treating BRCA-affected cancers." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in amg 404 for therapeutic use?

"The only new drug approved in the US for clinical use this year that is undergoing Phase 3-4 trials is amg 404, a therapeutic antibody. The other drugs and biologics in clinical research and development for therapeutic use have not been approved for clinical use this year. Thus, a major change has occurred not only for the future of cancer treatment, but also for clinical research and the creation of therapeutic proteins from research." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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