Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor: a Single Arm, Multiple Center, Phase II Study (Pigeon Study)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 sites30 target enrollmentAugust 15, 2024

ConditionsUrothelial Carcinoma Breast Neoplasms Lung Cancer Gastric Cancer Soft Tissue Sarcoma Other Carcinoma

InterventionsPemigatinib

DrugsPemigatinib

Overview

Phase: Phase 2
Intervention: Pemigatinib
Conditions: Urothelial Carcinoma
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment: 30
Primary Endpoint: Objective response rate (ORR)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This prospective phase Il study is aim to evaluate the efficacy and safety of FGFR inhibitor combined with immune checkpoint inhibitors in FGFR1/2/3 variant advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

August 15, 2024

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Responsible Party

Principal Investigator

qintao

associate chief physician

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility 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:
•Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L in the past 14 days without granulocyte colony-stimulating factor;
•Platelets ≥ 100 x 10⁹/L without transfusion in the past 14 days;

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:
•Serum phosphate \> 1.5 x ULN;
•Elevated serum calcium or albumin-adjusted calcium outside the reference range;
•Known HIV infection or positive HIV test;