OncoMatch/Clinical Trials/NCT05651672
Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations
Is NCT05651672 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pemigatinib for gastrointestinal cancer.
Treatment: Pemigatinib — This study is a prospective single-arm phase II study to evaluate the efficacy and safety of Pemigatinib in the advanced gastrointestinal cancer with FGFR 1-3 alterations and failed standard therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Biomarker criteria
Required: FGFR1 amplification
Required: FGFR1 fusion/rearrangement
Required: FGFR1 mutation
Required: FGFR2 amplification
Required: FGFR2 fusion/rearrangement
Required: FGFR2 mutation
Required: FGFR3 amplification
Required: FGFR3 fusion/rearrangement
Required: FGFR3 mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
Disease progression after prior standard therapy
Cannot have received: small molecule multi-target inhibitors targeting the FGFR pathway (anlotinib, lenvatinib, sorafenib, apatinib)
No previous use of small molecule multi-target inhibitors targeting the FGFR pathway (including but not limited to anlotinib, lenvatinib, sorafenib, apatinib)
Cannot have received: selective FGFR inhibitor
Prior receipt of selective FGFR inhibitors
Cannot have received: any other investigational drug or anti-tumor drug
Have received any other investigational drug or participated in another interventional clinical trial within 28 days before the first dose, or have received anti-tumor drug treatment within 28 days before the first dose (including Chinese herbal medicine with anti-tumor indications)
Cannot have received: radiotherapy
Have received radiotherapy within 4 weeks before the first dose.
Lab requirements
Blood counts
Sufficient organ functions required
Kidney function
Sufficient organ functions required
Liver function
Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis with Child-Pugh grade B or C excluded
Cardiac function
Clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III/IV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (patients with pacemakers or with atrial fibrillation but well controlled heart rate are allowed) excluded; ECG changes or medical history considered clinically significant by the investigator, QTcF interval > 480 ms at screening, JTc interval can be used instead of QTc interval (in such cases, JTc must be ≤ 340 ms) for patients with intraventricular conduction block (QRS interval > 120 ms) excluded; Uncontrolled hypertension (systolic pressure > 160 mmHg or diastolic pressure > 100 mmHg) after the optimal medical treatment, or a history of hypertensive crisis or hypertensive encephalopathy excluded
Sufficient organ functions; abnormal laboratory parameters listed below: Serum phosphate > ULN; Serum calcium exceeds the normal range, or the calcium concentration corrected for serum albumin exceeds the normal range when serum albumin exceeds the normal range; Potassium level < LLN (potassium levels can be corrected by supplements at screening)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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