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AMG 994

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Trials Updated: Jan 6, 2025

AMG 994 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

AMG 994 clinical trials

AMG 994 · 1 trial · 1 indication

Phase 1 1
NCT04727554Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED11 Analytics
PHASE1COMPLETED
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about AMG 994

What is AMG 994 used for?

AMG 994 is an investigational therapy being studied for the treatment of advanced solid tumors. It is a small molecule developed by Amgen Inc. and is currently in Phase 1 clinical development. The single completed trial enrolled 11 participants with advanced solid tumors across multiple countries.

Who makes AMG 994?

AMG 994 is being developed by Amgen Inc., a biotechnology company whose common stock trades on Nasdaq under the ticker symbol AMGN. Amgen is the sponsor of the clinical program evaluating AMG 994 in advanced solid tumors.

What phase is AMG 994 in?

AMG 994 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 11 participants and evaluated AMG 994 as a monotherapy and in combination with AMG 404 in advanced solid tumors.

What clinical trials is AMG 994 in?

AMG 994 has been evaluated in one Phase 1 clinical trial, NCT04727554, titled "Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors." The trial is completed and enrolled 11 participants across the United States, Australia, Belgium, Canada, France, Germany, Japan, Poland, Spain, and the United Kingdom.

Is AMG 994 biomarker-selected?

Yes, the AMG 994 Phase 1 trial NCT04727554 was biomarker-selected, meaning participants were enrolled based on specific biomarker criteria. The study evaluated AMG 994 as a monotherapy and in combination with AMG 404 in adults with advanced solid tumors.