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AMG 256

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04362748Study of AMG 256 in Adult Subjects With Advanced Solid TumorsPHASE1 COMPLETED 34 — — Sep 15, 2020Sep 21, 2023Oct 7, 202511 United States, Australia +2
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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