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FPA144

Phase 1

Gastric or Gastroesophageal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Jun 22, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05913115A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal CancerPHASE1 COMPLETED 6 — — Jun 12, 2017Jun 19, 2018Jun 22, 20232 Japan
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Study Endpoints
Primary Endpoints
Number of Participants who Experience Grade 3 or Grade 4 Dose-limiting Toxicities (DLTs)
Day 1 to Day 28 of Cycle 1

DLTs are defined as specific adverse events (AEs) or clinically laboratory abnormalities that occur during the DLT observation period (Day 1 to Day 28 of Cycle 1; cycle = 28 days), that the Cohort Review Committee (CRC) assess as related to FPA144. Events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 3: Severe or medically significant but non-immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE * Grade 4: Life-threatening consequences; urgent intervention indicated

Area Under Serum Concentration-time Curve (AUC) of FPA144
Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Maximum Serum Concentration (Cmax) of FPA144
Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Trough Serum Concentration (Ctrough) of FPA144
Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Clearance (CL) of FPA144
Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Terminal Half-life (t1/2) of FPA144
Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Volume of Distribution of FPA144
Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Secondary Endpoints
Number of Participants who Experience Treatment-emergent AEs (TEAEs)
Approximately 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
FPA144EXPERIMENTALParticipants will receive escalating doses of FPA144. On completion of Cycle 1 (Cycles = 28 days in length) participants may participate in an optional Extended Treatment Period based on the Investigator's discretion, which begins on Day 1 of Cycle 2. FPA144 will be administered once every 2 weeks (Q2W) in 4-week cycles until disease progression, or until the patient meets any of the other withdrawal criteria.
Interventions
NameTypeDescription
FPA144DRUGFPA144 will be administered intravenously Q2W.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment * Eastern Cooperative Oncology Group (ECOG) pe...

Countries:Japan
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