solid tumor (urothelial carcinoma, breast cancer et al)
Conditions
Interventions
Pemigatinib plus Immune Checkpoint:Pemigatinib plus Immune Checkpoint
Sponsors
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years; Histologically or cytologically confirmed unresectable advanced solid tumors with failure or intolerance to standard treatments; At least one measurable lesion per RECIST v1.1 criteria; Gene testing confirms FGFR1/2/3 variants, including but not limited to mutations, fusions/rearrangements in solid tumors; Patients have not previously used specific small molecule multi-target inhibitors of the FGFR pathway, as assessed by investigators, and have been treated with immune checkpoint inhibitors; ECOG performance status of 0-1; Expected survival time > 3 months; Laboratory criteria:
Exclusion criteria
Exclusion criteria: Diagnosis of other malignancies within 3 years before the first dose, except for certain treated skin carcinomas and in-situ carcinomas; Previous treatment with selective FGFR inhibitors; Receipt of other investigational drugs within 21 days or antitumor drugs within 14 days before the first dose; Unresolved toxicity from prior treatments unless = Grade 1 or related to alopecia or fatigue; Known symptomatic CNS metastasis or carcinomatous meningitis. Stable patients post-treatment with no evidence of progression may be eligible if steroid-free for at least 14 days; History of allogeneic organ or hematopoietic stem cell transplantation; Abnormal laboratory parameters: 1. Serum phosphate > 1.5 x ULN; 2. Elevated serum calcium or albumin-adjusted calcium outside the reference range; 8. Known HIV infection or positive HIV test; 9. Active or poorly controlled serious infection; 10. Need for drainage treatment for pleural effusion, ascites, or pericardial effusion; 11. Active hepatitis B or C infection with high viral load, or positive HBsAg or anti-HCV antibodies. Patients on antiviral therapy must meet lower thresholds; 12. Significant uncontrolled heart disease, including recent MI, severe heart failure, or uncontrolled arrhythmias; 13. Clinically significant ECG changes or history of significant cardiac issues; Screening QTcF interval > 480 ms, or JTc interval if applicable, must be = 340 ms; 14. Uncontrolled hypertension despite treatment; 15. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or higher cirrhosis; 16. Major surgery within 4 weeks before the first dose or planned major surgery during the study; 17. Unresolved complications from prior surgery; 18. Pregnant or breastfeeding women, or those planning to become pregnant during the study period and for safety follow-up; 19. Radiotherapy within 4 weeks before the first dose, except for non-CNS palliative radiotherapy with a 2-week washout period; 20. History of systemic electrolyte imbalance or ectopic soft tissue calcification; 21. Clinically significant corneal or retinal disease; 22. Use of potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before the first dose; 23. Known allergies to permitinib or its excipients; 24. Inability to ingest permitinib or significant digestive disorder affecting absorption; 25. History of vitamin D deficiency requiring supraphysiologic supplementation; 26. Grade 3 or higher irAEs from previous immune checkpoint inhibitor therapy; 27. Determined ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactTAO QIN
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Outcome results
None listed