NCT06551896尚未招募2 期
Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor: a Single Arm, Multiple Center, Phase II Study (Pigeon Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Hemoglobin > 9 g/dL in the last 14 days without transfusion or erythropoietin;
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or total bilirubin > ULN but direct bilirubin ≤ ULN;
- •AST, ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastasis);
- •Serum creatinine ≤ 1.5 x ULN and creatinine clearance (Cockcroft-Gault) ≥ 50 ml/min;
- •Good coagulation function, defined as INR or PT ≤ 1.5 x ULN. If on anticoagulant therapy, PT should be within the therapeutic range of anticoagulants;
- •Female subjects of reproductive age must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1, Day 1). If the urine test is inconclusive, a blood test is required. Non-reproductive females are defined as post-menopausal for at least one year or surgically sterile;
- •Subjects with reproductive potential must use contraception with an annual failure rate of less than 1% during treatment and for 120 days after the last study drug dose (or 180 days after the last chemotherapy dose).
排除标准
- •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;
- •Active or poorly controlled serious infection;
- •Need for drainage treatment for pleural effusion, ascites, or pericardial effusion;
- •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;
- •Significant uncontrolled heart disease, including recent MI, severe heart failure, or uncontrolled arrhythmias;
- •Clinically significant ECG changes or history of significant cardiac issues; Screening QTcF interval > 480 ms, or JTc interval if applicable, must be ≤ 340 ms;
- •Uncontrolled hypertension despite treatment;
- •Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or higher cirrhosis;
- •Major surgery within 4 weeks before the first dose or planned major surgery during the study;
- •Unresolved complications from prior surgery;
- •Pregnant or breastfeeding women, or those planning to become pregnant during the study period and for safety follow-up;
- •Radiotherapy within 4 weeks before the first dose, except for non-CNS palliative radiotherapy with a 2-week washout period;
- •History of systemic electrolyte imbalance or ectopic soft tissue calcification;
- •Clinically significant corneal or retinal disease;
- •Use of potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before the first dose;
研究组 & 干预措施
Pemigatinib combined with immune checkpoint inhibitor
Experimental
Pemigatinib 13.5mg，two weeks on and one week off, and with immune checkpoint inhibitor selected by investigator.
干预措施: Pemigatinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: every 8 weeks during treatment
the proportion of patients with tumor shrinkage with CR and PR over 4 weeks.
次要结局
- Disease control rate（DCR）(every 8 weeks during during treatment)
- Progression-free survival （PFS）(every 8 weeks during treatment)
- Overall survival（OS）(every 8 weeks during treatment)
研究者
qintao
associate chief physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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