Recent Updates
Recently added Catalysts

FPA144

Phase 1

Gastric or Gastroesophageal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Jun 22, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

FPA144 · 1 trial · 1 indication

Phase 1 1
NCT05913115A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal CancerGastric or Gastroesophageal Cancer
COMPLETED6 Analytics
PHASE1COMPLETED
A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer
Gastric or Gastroesophageal Cancer
NCT059131156
Unlock trial analytics

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
Unlock Study Endpoints

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.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about FPA144

What is FPA144 used for?

FPA144 is an investigational small molecule being studied for the treatment of gastric or gastroesophageal cancer. It is intended for patients with advanced forms of these cancers. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes FPA144?

FPA144 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the safety and pharmacokinetics of this investigational drug in patients with gastric or gastroesophageal cancer.

What phase is FPA144 in?

FPA144 is in Phase 1 clinical development. A Phase 1 study evaluating the drug in Japanese patients with advanced gastric or gastroesophageal cancer has been completed. The drug remains investigational and has not received regulatory approval for any use.

What clinical trials is FPA144 in?

FPA144 has been studied in one clinical trial, registered as NCT05913115. This was a Phase 1 study titled 'A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer.' The trial enrolled 6 participants and has been completed.

Is FPA144 FDA approved?

FPA144 is not FDA approved. It is an investigational drug that has been evaluated in a Phase 1 clinical trial for gastric or gastroesophageal cancer. The study has been completed, but the drug remains in clinical development and has not been authorized for marketing.