Clinical trial · Interventional
A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer
A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objectives of this study are: * To determine the recommended dose (RD) of FPA144 in participants with gastric or gastroesophageal cancer (hereafter referred to as gastric cancer) * To evaluate the safety of escalating doses of FPA144 in participants with gastric cancer * To characterize the pharmacokinetic (PK) profile of single and multiple doses of intravenously administered FPA144 in participants with gastric cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric or Gastroesophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FPA144 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FPA144
- description
- Participants 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.
- interventionNames
- Drug: FPA144
Primary outcomes (7)
- measure
- Number of Participants who Experience Grade 3 or Grade 4 Dose-limiting Toxicities (DLTs)
- timeFrame
- Day 1 to Day 28 of Cycle 1
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) performance status of 0 to 1 * Adequate hematological, liver and kidney function. Measurable or non-measurable disease * Archival tumor tissue for determination of FGFR2 status Key Exclusion Criteria: * Untreated or symptomatic central nervous system (CNS) metastases * Clinically significant cardiac disease * Peripheral sensory neuropathy \>/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 * Active infection requiring systemic treatment * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection * Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway * Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer * Known positivity for human epidermal growth factor receptor 2 (HER2) * Women who are pregnant or breastfeeding
References
Publications (0)
Data not yet available