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AMG 305

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Feb 17, 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 Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05800964Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 37Jun 13, 2023Jan 22, 2026Feb 17, 202627 United States, Australia +7
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Study Endpoints
Primary Endpoints
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
Day 1 to Day 28
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Up to a maximum of 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.

Percentage of Participants who Experience Treatment-Related Adverse Events
Up to a maximum of 2 years
Secondary Endpoints
Maximum Serum Concentration (Cmax) of AMG 305
Up to a maximum of 2 years
Minimum Serum Concentration (Cmin) of AMG 305
Up to a maximum of 2 years
Area Under the Concentration-Time Curve (AUC) of AMG 305
Up to a maximum of 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Dose ExplorationEXPERIMENTALParticipants will receive escalating doses of AMG 305.
Part B: Dose ExpansionEXPERIMENTALParticipants with selected solid tumors will receive the RP2D identified in Part A.
Interventions
NameTypeDescription
AMG 305DRUGShort-term intravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites27

Key Inclusion Criteria: * Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures * Male or female participants age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants with histologica...

Countries:United StatesAustraliaCanadaFranceGermanyJapanSouth KoreaSpainUnited Kingdom
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