Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations
NCT05019794 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2022-06-27
Summary
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 1-3. This is a multicenter, open-label, single arm phase IIa study to evaluate the efficacy and safety of Infigratinib in subjects with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification or other advanced solid tumors with other FGFR genetic alternations who have failed in 2nd line or above treatment. This trial includes 2 cohorts (i.e., baskets) with above mentioned indications.
Conditions
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Solid Tumor
Interventions
- DRUG
-
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Sponsors & Collaborators
-
LianBio LLC
lead INDUSTRY
Principal Investigators
-
Qiao Sun, Doctor · Shanghai LianBio Development Co., Ltd.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-13
- Primary Completion
- 2022-12-30
- Completion
- 2023-12-30
Countries
- China
Study Locations
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