A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) - BT8009-230

Bicycletx Limited0 个研究点目标入组 639 人开始时间: 2023年12月6日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Bicycletx Limited
入组人数: 639

研究概览入排标准研究者记录与标识符相似试验

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 65+（—）
性别: All

入选标准

•1. Able to understand the study procedures and agree to participate in the study by providing written informed consent., 10. WOCBP and male participants with female partners of childbearing potential willing to follow highly effective contraception at least as conservative as Clinical Trial Facilitation Group (CTFG) recommendations of < 1% failure rate starting at Screening, throughout the study period, and for at least 1 month following the last dose of avelumab, 4 months following the last dose of pembrolizumab, 6.5 months following the last dose of BT8009, and 6 months following the last dose of platinum treatment or gemcitabine, whichever comes last., 11. Fertile male participants must agree to refrain from sperm donation from first dose until at least 1 month following the last dose of avelumab, 4 months following the last dose of pembrolizumab, 6.5 months following the last dose of BT8009, and 6 months following the last dose of platinum treatment or gemcitabine, whichever comes last. Women must not breastfeed or donate eggs from first dose until 1 month following the last dose of avelumab, 4 months following the last dose of pembrolizumab, 6.5 months following the last dose of BT8009, and 6 months following the last dose of platinum treatment or gemcitabine, whichever comes last., Additional cohort specific inclusion criteria may apply (see synopses), 2. = 18 years of age on day of signing informed consent., 3. Histologically or cytologically confirmed locally advanced (unresectable) or metastatic UC of the renal pelvis, ureter, bladder, or urethra. a. Participants with mixed histologies are required to have a dominant transitional cell pattern (= 50%)., 4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. a. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions post irradiation., 5. Archival or fresh tumor tissue comprising muscle-invasive UC, or locally advanced or metastatic UC should be available for submission to central laboratory., 6. Life expectancy = 12 weeks., 7. Adequate organ function: a. Total bilirubin = 1.5 × upper limit of normal (ULN) or = 3 × ULN for participants with Gilbert disease b. Serum albumin = 2.5 g/dL c. Aspartate aminotransferase (AST) = 2.5 × ULN or = 5 × ULN in the presence of liver metastases d. Alanine aminotransferase (ALT) = 2.5 × ULN or = 5 × ULN in the presence of liver metastases e. Alkaline phosphatase = 2.5 × ULN or = 5 × ULN in the presence of liver or bone metastases f. Estimated glomerular filtration rate (eGFR) = 30 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation adjusted by the patient’s body surface area), 8. International normalized ratio (INR)/prothrombin time (PT) = 1.5 × ULN unless participant is receiving a stable dose of anticoagulant therapy and PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of the appropriate anticoagulants., 9. Negative pregnancy test for women of childbearing potential (WOCBP) (negative serum test at Screening and negative urine or serum test within 72 hours prior to the first dose).

排除标准

•1. Active keratitis or corneal ulcerations., 10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)., 11. Uncontrolled hypertension (HTN) (systolic blood pressure (BP) = 150 mm mercury (Hg) or diastolic BP = 95 mm Hg) prior to first dose., 12. Prior allogeneic stem cell or solid organ transplantation., 13. Active interstitial lung disease or pneumonitis, or a history of interstitial lung disease or pneumonitis requiring treatment with steroids or other immunosuppressive medications., 14. Prior treatment with an agent directed to another stimulatory or co-inhibitory T-cell receptor., 15. Prior treatment with any systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is longer, prior to initiation of study treatment; the following exceptions are permitted: a. Palliative radiotherapy for UC-related bone or soft tissue metastasis completed > 7 days prior to baseline imaging. b. Androgen deprivation therapy using gonadotropin-releasing hormone (GnRH) agonists. c. Females with hormone receptor-positive breast cancer who are receiving tamoxifen or aromatase inhibitors adjuvant therapy = 3 years., 16. Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 2 weeks or 5 half-lives, whichever is longer, prior to first dose of study treatment., 17. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)., 18. Any prior Grade = 3 immune-related adverse event while receiving immune checkpoint inhibitor., 19. Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). a. Well controlled HIV will be allowed if the participant meets all the following criteria at inclusion: i. Cluster of differentiation (CD4+) counts = 350 cells/uL; ii. HIV viral load < 400 copies/mL; iii. Without a history of opportunistic infection within the last 12 months; iv. On established antiretroviral therapy (ART) for at least 4 weeks., 2. Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors., 20. Known active hepatitis B, defined as positive surface antigen and/or anti-hepatitis B core antibody. Participants with a negative polymerase chain reaction assay are permitted with appropriate antiviral therapy., 21. Known active hepatitis C infection with positive viral load if hepatitis C virus is antibody positive (if antibody is negative then viral load is not applicable). Participants who have been treated for hepatitis C infection can be included if they have documented sustained virologic response of = 12 weeks., 22. History or another active malignancy that would interfere with the safety or efficacy evaluation of the clinical study., 24. Suspicion of relevant and recent systemic viral syndrome or need for quarantine/isolation that is not resolved prior to initiation of study treatment in the opinion of the Investigator., 25. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s ability to take part in the full duration of the study, or is not in the best interest of the participant to take part

研究者

发起方

Bicycletx Limited

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