EUCTR2017-001292-23-FR进行中（未招募）1 期
A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined with Pembrolizumab in Subjects with Locally Advanced or Metastatic Urothelial Carcinoma who have Progressed Following Platinum-based Chemotherapy. - FIERCE-22
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Have locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including the urinary bladder, urethra, ureter, and/or renal pelvis. The diagnosis must be histologically or cytologically confirmed.
- •2. Have progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- •3.Have available archival tumor or be willing to undergo diagnostic biopsy at screening. Sample must be of suitable quality and quantity to satisfy group assignment and biomarker endpoints (as described in the Study Manual).
- •4. Have measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- •5. Male and female subjects, age = 18 years.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1 (see Appendix 1).
- •7. Willingness to avoid pregnancy or fathering children based on the criteria as described in study protocol.
- •8. Ability to understand and sign informed consent form (ICF) and comply with all study procedures
- •9. Have adequate hematologic and end organ function defined by the following laboratory results obtained within 2 weeks prior to the first dose of study treatment:
- •a) Absolute neutrophil count = 1,500/µL.
- •b) Platelet count = 100,000/µL.
- •c) Hemoglobin = 9.0 g/dL without transfusion.
- •d) Albumin = 2.5 g/dL.
- •e) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 2.5 × upper limit of normal (ULN), with the following exceptions:
- •- Subjects with documented bone metastases: ALP = 5 × ULN.
- •- Creatinine clearance = 30 mL/min on the basis of the Cockroft Gault glomerular filtration rate estimation: ((140-age)×(weight in kg)×(0.85 if female) )/(72×(serum creatinine in mg/dL))
- •f) Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) must be = 1.5 × ULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 83
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan.
- •2. Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent, or with an agent directed to another co-inhibitory T-cell receptor or FGFR inhibitor.
- •3. Patients with autoimmune disease or medical conditions that required systemic corticosteroids (> 10 mg/day prednisone or its equivalent) or other immunosuppressive medications or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment. Note Replacement therapy (e.g. physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- •4. Prior anti-cancer therapy (e.g. biologic or other targeted therapy, chemotherapy or hormonal therapy) within 14 days prior to the first dose of study medication.
- •A washout of less than 14 days may be allowed after discussion with the Medical Monitor, provided that the subject has recovered from any clinically relevant toxicity (Exception: participants with neuropathy of Grade 1 will be allowed study entry).
- •5. Acute clinical AEs, except for alopecia, from any previous treatments must have resolved to = Grade 1 or chronic defined as present for more than 6 months without worsening and not greater than Grade 2.
- •6. Laboratory AEs from any previous treatments must have resolved to = Grade 1 or to within 10% of baseline prior to the first dose of study treatment.
- •7. Participants who are receiving or have received any other investigational drugs or devices within in the 2 weeks prior to the first dose of study medications.
- •8. Participants with a diagnosis of immunodeficiency.
- •9. Primary central nervous system (CNS) malignancy or CNS metastases.
- •10. Participants with a history of allergic reactions attributed to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
- •11. History of major bleeding (requiring a blood transfusion = 2 units) not related to a tumor within the past 12 months.
- •12. History of clinically significant coagulation or platelet disorder in the past 12 months.
- •13. Participants receiving anticoagulation treatment.
- •14. Participants who have not recovered adequately from the toxicity and/or complications from the interventions prior to starting therapy.
- •15. Incomplete healing from wounds from prior surgery (wounds larger than 2 cm in length) within 28 days prior to first dose of study treatment.
- •16. Participants with an active uncontrolled infection requiring systemic therapy (e.g., IV antibiotics or antifunagal therapy).
- •Note: The use of oral anti-infectious agents for prophylaxis or treatment of resolving infections is not considered exclusionary under this rule.
- •17. Participants who have received a live vaccine within 30 days of planned start of study therapy.
- •Note: Seasonal influenza vaccines with inactivated flu vaccines are allowed; however, live attenuated vaccines such as intranasal influenza vaccines (e.g., Flu Mist®) are not allowe
研究者
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A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined with Pembrolizumab in Subjects with Locally Advanced or Metastatic Urothelial Carcinoma who have Progressed Following Platinum-based Chemotherapy or are not eligible for cisplatin-containing chemotherapy.Transitional cell carcinoma10038364Bladder cancerNL-OMON48991Rainier Therapeutics, Inc.2
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