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AMG 256

Phase 1

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

AMG 256 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2020

AMG 256 target and mechanism

Molecular targetPD-1
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

AMG 256 clinical trials

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 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about AMG 256

What is AMG 256 used for?

AMG 256 is an investigational therapy being studied for the treatment of advanced solid tumors. It is a small molecule developed by Amgen Inc. and has been evaluated in a Phase 1 clinical trial in adult patients with advanced solid tumors. It is not approved for any indication.

What does AMG 256 target?

AMG 256 targets PD-1, a protein that functions as an immune checkpoint. By binding to PD-1, the drug is designed to interfere with PD-1 mediated signaling in the tumor microenvironment. This mechanism is intended to support antitumor immune activity in patients with advanced solid tumors.

Who makes AMG 256?

AMG 256 is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program evaluating AMG 256 in advanced solid tumors.

What phase is AMG 256 in?

AMG 256 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA for any indication. The Phase 1 study in advanced solid tumors has been completed.

What clinical trials is AMG 256 in?

AMG 256 has been evaluated in one clinical trial, NCT04362748, titled Study of AMG 256 in Adult Subjects With Advanced Solid Tumors. This completed Phase 1 trial enrolled 34 adult patients across the United States, Australia, Belgium, and Spain. It was a controlled study without randomization or double blinding.