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AMG 355

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

AMG 355 · 1 trial · 1 indication

Phase 1 1
NCT06131398A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED77 Analytics
PHASE1COMPLETED
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Recent Changes (Last 90 Days)

HIGHAug 11, 2026NCT06131398Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 11, 2026NCT06131398Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about AMG 355

What is AMG 355 used for?

AMG 355 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being evaluated in a Phase 1 clinical trial, both alone and in combination with pembrolizumab, in participants with advanced solid tumors. The drug is not yet approved and remains in clinical development.

Who makes AMG 355?

AMG 355 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting a Phase 1 clinical trial of AMG 355 in patients with advanced solid tumors.

What phase is AMG 355 in?

AMG 355 is in Phase 1 clinical development. It is an investigational drug being studied for advanced solid tumors, and it has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is AMG 355 in?

AMG 355 is being studied in a Phase 1 clinical trial with the identifier NCT06131398. This trial evaluates AMG 355 alone and in combination with pembrolizumab in participants with advanced solid tumors. The trial has been completed and enrolled 77 participants.

Is AMG 355 the same as pembrolizumab?

No, AMG 355 is not the same as pembrolizumab. AMG 355 is an investigational small molecule being developed by Amgen, while pembrolizumab is an approved immunotherapy. The Phase 1 trial NCT06131398 studies AMG 355 alone and in combination with pembrolizumab.