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AMG 994

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Jan 6, 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 Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04727554Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid TumorsPHASE1 COMPLETED 11Apr 29, 2021Jun 5, 2023Jan 6, 202517 United States, Australia +8
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Up to Day 28 of Cycle 1 (one cycle = 28 days)

DLTs were defined as: * Grade 5 events * Grade 4 neutropenia/thrombocytopenia of any duration * Grade 3 thrombocytopenia w/ clin significant bleeding or lasting \>7 days * Febrile neutropenia * Grade 4 anemia * Grade 3/4 non-hematologic toxicity, except: Grade 3 nausea/vomiting or diarrhea \< 72 hours; Grade 3 fatigue \< 1 week; Asymptomatic grade 3 electrolyte abnormalities that last \< 72 hours, are not clinically complicated, and resolve spontaneously or respond to conventional medical interventions; Grade 3 amylase/ lipase elevations; Other laboratory parameters of grade 3, not considered clinically relevant and improved to grade ≤ 2 within 72 hours. * Any grade 3 event requiring hospitalization * Recurrent grade 2 pneumonitis * Delay in cycle 2 treatment for \> 14 days due to an adverse event in the dose escalation portion of the study * Any event requiring discontinuation of AMG 994

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
From first dose of investigational product through 140 days after last dose (AMG 994 or AMG 404, whichever is later), or end of study (whichever is first); median (min, max) duration was 12.5 ( 1.48, 19.32) months.

TEAEs were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the CTCAE Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.

Secondary Endpoints
Objective Response (OR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Up to approximately 19.32 months
Duration of Response (DoR) Per Modified RECIST 1.1
Up to approximately 19.32 months
Overall Survival (OS) Per Modified RECIST 1.1
Up to approximately 19.32 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1a: Dose ExplorationEXPERIMENTALDetermine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.
Part 1b: Dose ExplorationEXPERIMENTALDetermine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.
Part 1c: Dose ExplorationEXPERIMENTALDetermine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.
Part 2: Dose ExpansionEXPERIMENTALParticipants will be administered with the MTD or RP2D of AMG 994 identified in the dose escalation part of the study, in combination with AMG 404.
Interventions
NameTypeDescription
AMG 994DRUGAdministered as an intravenous (IV) infusion.
AMG 404DRUGAdministered as an intravenous (IV) infusion.
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Participant has provided informed consent/assent 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 histologica...

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyJapanPolandSpainUnited Kingdom
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