NL-OMON48991撤回不适用
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. - FIERCE-22
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •For subjects in the Phase 2 MF cohort, tumors must have at least one of the
- •following FGFR3 mutations: R248C, S249C, G370/2C, S371/3C, Y373/5C, G380/82R,
- •F384/6L, K650/2X (X<=E,T or M) or FGFR3- TACC3 fusion, as shown by tests
- •performed by a CAP or CLIA certified laboratory (or equivalent outside of the
- •US) on samples that were obtained at or after the time when the subject was
- •found to have muscle invasive / metastatic disease or high grade papillary
- •non-muscle invasive disease.
- •In the absence of pre-existing genetic test results, subjects can submit
- •archival tissue (obtained at or after the time subject was found to have muscle
- •invasive / metastatic disease) for genetic testing. If no suitable tissue is
- •available, a blood sample may be used to determine FGFR3 genetic status.
- •Subsequent to subject enrollment, blood samples used to determine FGFR3 status,
- •or previous test results that were not provided by Foundation Medicine will be
- •verified using archival tissue or the first biomarker tumor biopsy sample.
- •2. Have progression during or following platinum-containing chemotherapy in
- •metastatic setting or within 12 months of neoadjuvant or adjuvant treatment
- •with platinum-containing chemotherapy
- •Have a PD-L1 positive tumor (per label) at the time of metastatic disease, and
- •are not eligible for cisplatin-containing chemotherapy defined as meeting any
- •of the following criteria:
- •- Creatinine clearance <60 mL/min (GFR by direct measurement, or using
- •Cockcroft-Gault equation)
- •- Equal to or greater than grade 2 hearing loss
- •- Equal to or greater than grade 2 peripheral neuropathy
- •- New York Heart Association Class III heart failure
- •3. Have available archival tumor or be willing to undergo diagnostic biopsy
- •during screening.
- •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
- •a. Women of non-childbearing potential (i.e., surgically sterile with a
- •hysterectomy and/or bilateral oophorectomy OR chemically sterile OR ? 12 months
- •of amenorrhea in the absence of chemotherapy, anti-estrogens, or ovarian
- •suppression). Women of non-childbearing potential need not undergo pregnancy
- •b. Women of childbearing potential who have a negative urine or serum pregnancy
- •test at Screening and before the first dose of study drug and who agree to take
- •appropriate precautions to avoid pregnancy (with approximately 99% certainty)
- •from Screening through 120 days after the last dose of study drug. Permitted
- •methods of contraception that are approximately 99% effective in preventing
- •pregnancy are described in Appendix 4, should be communicated to the subject,
- •and the subject*s understanding confirmed.
- •c. Men who agree to take appropriate precautions to avoid fathering children
- •(with at least 99% certainty) from Screening through
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
- •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 treatment.
- •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
- •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 14 days 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 who have not recovered adequately from the toxicity and/or
- •complications from the interventions prior to starting therapy.
- •14. Incomplete healing from wounds from prior surgery (wounds larger than 2 cm
- •in length) within 28 days prior to the first dose of study treatment
- •15. Participants with an active uncontrolled infection requiring systemic
- •therapy (e.g., IV antibiotics or antifungal therapy).
- •Note: The use of oral anti-infectious agents for prophylaxis or treatment of
- •resolving infections is not considered exclusionary under this rule.
- •16. 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 allowed.
- •17. Participants with uncontrolled intercurrent illness including, but not
- •limited to, ongoing or symptomatic congestive heart failure, unstable angina
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研究者
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