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AMG 650

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Aug 24, 2023

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 Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04293094Study of AMG 650 in Adult Participants With Advanced Solid TumorsPHASE1 COMPLETED 66 — — Mar 11, 2020Feb 15, 2023Aug 24, 202322 United States, Australia +5
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Study Endpoints
Primary Endpoints
Number of Participants with Dose Limiting Toxicities (DLTs)
Up to 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Up to 24 months
Number of Participants with Serious Adverse Events (SAEs)
Up to 24 months
Number of Participants with Treatment-related Adverse Events
Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement
Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Up to 24 months
Secondary Endpoints
Objective Response Rate (ORR)
Up to 24 months
Duration of Response (DOR)
Up to 24 months
Progression-free Survival (PFS)
Up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Exploration PhaseEXPERIMENTALParticipants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD.
Dose Expansion Phase Group 1: TNBCEXPERIMENTALParticipants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
Dose Expansion Phase Group 2: HGSOCEXPERIMENTALParticipants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
Interventions
NameTypeDescription
AMG 650DRUGAMG 650 administered orally as a tablet.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Male and female ≥ 18 years old * Triple Negative Breast Cancer participants only: Participant must have histologically or cytologically confirmed metastatic or locally recurrent estrogen receptor (ER)-negative (\<1% by immunohistochemistry \[IHC\]), progesterone receptor (PR)-...

Countries:United StatesAustraliaBelgiumCanadaItalyJapanSpain
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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