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AMG 256 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 up to 2.5 years

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and how well it works.

Eligible Conditions

Advanced Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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

Maximum Tolerated Dose (MTD) of AMG 256

Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests

Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement

+4 more

Secondary outcome measures

Area Under the Plasma Concentration-time Curve (AUC) of AMG 256

Disease Control Rate (DCR)

Duration of Response (DOR)

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion Phase: Group 2Experimental Treatment1 Intervention

Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.

Group II: Dose Expansion Phase: Group 1Experimental Treatment1 Intervention

Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.

Group III: Dose Escalation PhaseExperimental Treatment1 Intervention

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMG 256

2020

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,654 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

924,097 Total Patients Enrolled

Media Library

AMG 256 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04362748 — Phase 1

Solid Tumors Research Study Groups: Dose Escalation Phase, Dose Expansion Phase: Group 1, Dose Expansion Phase: Group 2

Solid Tumors Clinical Trial 2023: AMG 256 Highlights & Side Effects. Trial Name: NCT04362748 — Phase 1

AMG 256 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04362748 — Phase 1

Frequently Asked Questions

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

Could I potentially become a participant in this medical experiment?

"To qualify for this trial, candidates must have solid tumors or advanced solid tumor types and should be between 18 to 100 years of age. The research team is hoping to recruit a total cohort size of one hundred individuals."

Answered by AI

Could you provide an assessment of the safety profile for AMG 256?

"Our experts at Power have assigned AMG 256 a rating of 1, as it is in the early stages of clinical trials and only has scant evidence to support its safety or efficacy."

Answered by AI

In how many locales is this clinical investigation being conducted?

"This clinical trial is enrolling patients at the City of Hope National Medical Center in Duarte, California, Washington University in Saint Louis, Missouri and the University of Texas MD Anderson Cancer Centre in Houston. Additionally 4 additional sites are participating."

Answered by AI

Is eligibility for the clinical trial restricted to individuals over sixty years old?

"To be included in this medical experiment, patients must fit within the age bracket of 18-100. For those under 18 and over 65 years old, there are 303 and 2316 different trials respectively."

Answered by AI

Is there currently an enrollment period for this clinical experiment?

"According to clinicaltrials.gov, this medical trial has finished recruiting participants since its first posting on September 15th 2020 and last update on the 27th of September 2022. Nevertheless, there are still 2502 other studies actively searching for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

2020. "Study of AMG 256 in Adult Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04362748.