CTIS2024-513312-95-00招募中1 期
An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma - CA-4948-101
Curis Inc.0 个研究点目标入组 80 人开始时间: 2024年5月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- •Part A2 and B. 01. Males and females >= 18 years of age, Part B. 08. Acceptable organ function at Screening within 28-days prior to Cycle 1 Day 1 as described below: a. ANC = 1,000/µL b. Platelet count = 75,000/µL without transfusion c. Estimated creatinine clearance of = 35 mL/min d. Hemoglobin = 9.0 g/dL and without red blood cell (RBC) transfusion e. International normalized ratio (INR) = 1.5 and activated partial thromboplastin time (aPTT) = 1.5× ULN f.AST or ALT = 2× ULN g. Total bilirubin = 1.5× ULN or = 3× ULN in patients with documented Gilbert’s syndrome, Part B. 09.CPK elevation < 2.5× ULN, Part A2 and B. 02. Life expectancy of at least 3 months, Part B. 10.For patients on a cholesterol lowering agent that has been associated with CPK elevations, such as statins or fibrates, the agent should be discontinued or replaced with an alternative if medically feasible. Otherwise, it should be reduced to the lowest dose that is biologically effective (ie, the lowest dose required to achieve the desired clinical effect)., Part A2 and B. 03. ECOG Performance Status of = 1, Part A2. 04. Diagnosis of histopathologically confirmed B-cell NHL, as per the WHO 2016 classification (Swerdlow et al. 2016). Eligible NHL subtypes include follicular lymphoma, MZL, MCL, DLBCL (including extranodal lymphomas of leg-, testicular-, or NOS [not otherwise specified]-type), and primary or secondary central nervous system (CNS) lymphoma. NOTE: Once a dose has been shown not to exceed the MTD in NHL patients, other hematological malignancies can be considered for enrollment in specific malignancies that have been approved by the CSC and Sponsor. Patients with MCL or MZL should meet clinical criteria for requiring treatment of their disease., Part A2. 05. Relapsed or refractory disease (as defined below) for which patients are ineligible for or have exhausted standard therapeutic options that would be considered standard of care. a. Relapsed NHL is per Revised Response Criteria for Malignant Lymphoma and as documented by excisional/incisional biopsy (preferred) or FNA or CNB as PD after a CR, PR, or stable disease. NOTE: For confirmation of documented relapse during prior treatment, biopsy/FNA of the lymphoma at Screening is recommended but not mandatory. b. Refractory NHL is defined for all eligible NHL by PD (per Revised Response Criteria for Malignant Lymphoma) during prior treatment or failure to achieve an objective response on prior treatment. NOTE: Biopsy (preferred) or FNA at Screening is recommended but not mandatory., Part A2. 06. Measurable disease: Defined as CT scan showing at least 1 clearly demarcated lymph node(s) with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated extranodal lesion(s) with a long axis > 1.0 cm and short axis > 1.0 cm. All lesions must have a maximum diameter of < 10 cm., Part A2. 07. Must have recovered from toxicity after any prior autologous stem cell transplants or CAR-T cell therapy, and must have disease progression prior to initiation of study treatment, Part A2. 08. Acceptable marrow and organ function at Screening as described below: a.ANC = 1,000/µL* b.Platelet count = 50,000/µL without transfusion within 1 week prior to start of study treatment* c. SCr = 1.5× ULN or a calculated creatinine clearance = 30 mL/min according to Cockcroft Gault formula (using actual body weight) or by 24-hour urine collection d. AST or ALT = 2× ULN e. Total bilirubin = 1.5× ULN or = 3 × ULN in patients wit
排除标准
- •Part A2. 01. Patients with active CNS involvement other than PCNSL at study entry are ineligible. Patients with prior CNS disease (leptomeningeal disease or brain metastasis) that has been adequately treated (eg, radiation or intravenous or intrathecal chemotherapy) are permitted, but must have completed such treatment and have no evidence of active CNS disease for at least 4 weeks prior to the first dose of study treatment. Intrathecal chemoprophylaxis to prevent the emergence or recurrence of lymphoma in the CNS is permitted on study during dose expansion only and may be administered per institutional guidelines., Part A2. 19. Any other severe, acute, or chronic medical, psychiatric, or social condition, or laboratory abnormality that may increase the risk of trial participation or study treatment administration, may interfere with the informed consent process and/or with compliance with the requirements of the trial, or may interfere with the interpretation of the trial results and, in the Investigator’s opinion, would make the patient inappropriate for entry into this trial., Part A2. 20. B-cell NHL of the following subtypes: a. Burkitt lymphoma b. Lymphoblastic lymphoma or leukemia c. Post-transplantation lymphoproliferative disorder d. Known primary mediastinal, ocular, or epidural DLBCL, Part A2. 02. Radiotherapy delivered to non-target lesions involving > 25% of bone marrow within 1 week prior to starting study treatment or delivered to target lesions that will be followed on the study NOTE: Prior sites of radiation will be recorded., Part A2 and Part B: - Part A2 (04) Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days prior to the start of study treatment (with the exception of ibrutinib for Parts A2 and B, which may be continued as part of this study without interruption). - Part B (07). Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib for Parts A2 and B, which may be continued as part of this study without interruption), Part A2. 05. Current or planned glucocorticoid therapy, with the following exceptions: a.Doses = 10 mg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of study treatment. b.Inhaled, intranasal, intra-articular, and topical steroids are permitted., Part A2. 06. Use of any investigational agent within 21 days or 5 half-lives, whichever is shorter, prior to start of study treatment, Part A2. 07. Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy, with the exception of alopecia, that has not resolved to Grade = 1, as determined by NCI CTCAE v4.03, within 7 days prior to the start of study treatment unless approved by the Medical Monitor, Part A2. 08. Known allergy or hypersensitivity to any component of the formulation of CA-4948 (or ibrutinib for entry into Parts A2 or B) used in this study, Part A2. 09. Major surgery, other than diagnostic surgery, < 28 days from the start of study treatment; minor surgery < 14 days from the start of study treatment NOTE: Insertion of a vascular access device is not considered minor surgery., Part A2. 10. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-rel
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