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AMG 256

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Oct 7, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

AMG 256 · 1 trial · 1 indication

Phase 1 1
NCT04362748Study of AMG 256 in Adult Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED34 Analytics
PHASE1COMPLETED
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Dose Limiting Toxicities (DLTs)
28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Up to 2.5 Years
Number of Participants with Treatment-Related Adverse Events
Up to 2.5 Years
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
Up to 2 Years
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Up to 2 Years
Maximum Tolerated Dose (MTD) of AMG 256
28 days
Recommended Phase 2 Dose (RP2D) of AMG 256
28 days

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) of AMG 256
Up to 2.5 Years
Time to Achieve Cmax (Tmax) of AMG 256
Up to 2.5 Years
Area Under the Plasma Concentration-time Curve (AUC) of AMG 256
Up to 2.5 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation PhaseEXPERIMENTALDetermine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.
Dose Expansion Phase: Group 1EXPERIMENTALParticipants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
Dose Expansion Phase: Group 2EXPERIMENTALParticipants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.

Interventions

NameTypeDescription
AMG 256DRUGAMG 256 administered as an intravenous (IV) infusion.
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years at the time of signing informed consent. * Life expectancy of \> 3 months, in the opinion of the investigator. * Participant must have histologically or ...

Countries:United StatesAustraliaBelgiumSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about AMG 256

What is AMG 256 used for?

AMG 256 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has been studied in adult subjects with advanced solid tumors. The drug is not approved and remains under investigation.

What does AMG 256 target?

The specific molecular target of AMG 256 has not been disclosed. It is a small molecule modality being studied in oncology for advanced solid tumors. Without a disclosed target, its mechanism of action is not publicly characterized.

Who makes AMG 256?

AMG 256 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The company is conducting clinical research on this investigational oncology drug.

What phase is AMG 256 in?

AMG 256 is in Phase 1 clinical development. One Phase 1 study has been completed, which enrolled 34 adult subjects with advanced solid tumors. The drug is investigational and has not received FDA approval.

What clinical trials is AMG 256 in?

AMG 256 has one completed clinical trial, NCT04362748, titled "Study of AMG 256 in Adult Subjects With Advanced Solid Tumors." This Phase 1 study enrolled 34 participants across the United States, Australia, Belgium, and Spain.

Is AMG 256 the same as any other drug?

No alternative names for AMG 256 have been disclosed. It is identified solely by its development code AMG 256 and is being studied as a monotherapy in advanced solid tumors.