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AMG 355

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: May 28, 2026

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 Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06131398A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 77Mar 7, 2024Jul 21, 2026May 28, 202625 United States, Australia +9
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Study Endpoints
Primary Endpoints
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Day 1 to Day 21
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Up to 2 years

Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.

Number of Participants Who Experience a Treatment-related AE
Up to 2 years
Secondary Endpoints
Maximum Observed Serum Concentration (Cmax) of AMG 355
Up to 85 days
Minimum Observed Serum Concentration (Cmin) of AMG 355
Up to 85 days
Area Under the Concentration-time Curve (AUC) of AMG 355
Up to 85 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Group A: AMG 355 monotherapyEXPERIMENTALSpecified dose on specified days
Group B: AMG 355 and pembrolizumabEXPERIMENTALSpecified dose on specified days
Interventions
NameTypeDescription
AMG 355DRUGShort-term intravenous (IV) infusion
PembrolizumabDRUGShort-term IV infusion
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites25

Key Inclusion Criteria: * Age ≥ 18 years at the time of signing informed consent. * Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with kno...

Countries:United StatesAustraliaCanadaFranceJapanNetherlandsPolandSouth KoreaSpainSwitzerlandTaiwan
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT06131398primaryCompletionDate: changed
LOWMay 29, 2026NCT06131398primaryCompletionDate: changed
LOWMay 29, 2026NCT06131398primaryCompletionDate: changed
LOWMay 26, 2026NCT06131398primaryCompletionDate: changed
LOWMay 24, 2026NCT06131398studyFirstPostDate: changed