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AMG 404

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Jul 20, 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 Enrollment171
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03853109AMG 404 in Patients With Advanced Solid TumorsPHASE1 COMPLETED 171Mar 5, 2019Nov 2, 2023Jul 20, 202534 United States, Australia +11
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Up to Day 28

Toxicities were graded with the Common Terminology Criteria for Adverse Events CTCAE v5.0., the following toxicities were classified as DLTs: * Any treatment related grade 5 toxicity * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 4 anemia * Grade 3 or 4 non-hematologic toxicity * Recurrent grade 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Up to the last dose of AMG 404 + 140 days (approximately 46 months); median (min, max) exposure to AMG 404 was 3.58 (0.02, 41.7) months

A TEAE is any adverse event (AE) starting on or after the first administration of investigational product (IP) and up to and including 140 days after the last IP dose date or end of the study, whichever occurs earlier. A TEAE with unknown/missing relatedness to AMG 404 is assumed as an event is related to AMG 404. A serious adverse event (SAE) is defined as an adverse event that: is fatal, is life threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important serious event. A treatment-related AE (TRAE) is any TEAE that per investigator review has a reasonable possibility of being caused by the investigational product. In the unlikely event that the relationship is missing, the TEAE will be considered TRAE and documented in a footnote of the treatment-related summary.

Secondary Endpoints
AMG 404 Pharmacokinetic (PK) Parameter by Dose Group: Maximum Observed Serum Concentration (Cmax) During Cycle 1 and 2
Day 1 pre-dose, end of infusion (EOI), 2h, 4h post dose; Day 2; Day 4; Day 8; Day 15 of Cycle 1 and 2 (28 day cycle length)
AMG 404 PK Parameter by Dose Group: Time to Achieve Cmax (Tmax) During Cycle 1 and 2
Day 1 pre-dose, end of infusion (EOI), 2h, 4h post dose; Day 2; Day 4; Day 8; Day 15 of Cycle 1 and 2 (28 day cycle length)
AMG 404 PK Parameter by Dose Group: Area Under the Serum Concentration-time Curve From Day 0 to Day 28 (AUC0-28d) During Cycle 1 and 2
Day 1 pre-dose, end of infusion (EOI), 2h, 4h post dose; Day 2; Day 4; Day 8; Day 15 of Cycle 1 and 2 (28 day cycle length)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALCohort 1
Cohort 2EXPERIMENTALCohort 2
Cohort 3EXPERIMENTALCohort 3
Cohort 4EXPERIMENTALCohort 4
Cohort 6EXPERIMENTALCohort 6
Cohort 7EXPERIMENTALCohort 7
Cohort 8EXPERIMENTALCohort 8
Cohort 9EXPERIMENTALCohort 9
Interventions
NameTypeDescription
AMG 404DRUGAMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study specific activities/procedures. * Age greater than or equal to 18 years old at the time of signing informed consent. * Life expectancy of greater than 3 months, in the opinion of the investigator * Subject ...

Countries:United StatesAustraliaBelgiumBrazilCanadaJapanPolandSingaporeSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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