CTIS2024-516290-67-00招募中1 期
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF CYC140, AN ORAL PLK1 INHIBITOR, IN SUBJECTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA - CYC140-101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 330
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
- •Male or females aged # 18 years or per local regulatory guidance, Subjects with histological or cytologically-confirmed advanced cancer who have progressed on (or have not been able to tolerate) standard therapy or for whom no standard anticancer therapy is available a. For phase 1, all tumor types may be enrolled b. For phase 2, subjects will be enrolled as mentioned in the ‘study design’ section c. For phase 2, subjects should also meet the following criteria: i. Radiological progression as per RECIST (Lugano criteria for lymphoma, modified severity-weighted assessment tool [mSWAT] for CTCL) criteria on the last line of therapy before entering the trial must be documented ii. At least one measurable lesion as defined by the RECIST criteria (version 1.1) for solid tumors iii. For subjects with lymphoma based on Lugano Criteria (Cheson et al. 2014) and CTCL subjects based on mSWAT (Olsen), Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2, Subjects who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease., WOCBP must have a negative pregnancy test (urine/serum) within 7 days prior initiating the study drug. Both males and females must agree to use effective birth control during the study (prior receiving first dose and for 6 months after the last dose) if conception is possible during this interval. Female subjects are considered to not be of childbearing potential if they have a history of hysterectomy or are postmenopausal (no menses for 12 months without an alternative medical cause). For both males and females, see Section 5.5 for the definitions of contraceptive methods considered effective for this protocol, Subjects must be able to swallow and retain orally administered medication, and not have any clinically significant GI abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels, Ability to agree to and sign the informed consent form, and comply with the protocol
排除标准
- •Subjects with a history of brain metastases or with signs/symptoms attributable to brain metastases and those who have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible, Subjects who have not received vaccines for SARS-COV-2 and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19 Exclusions owing to medical conditions, Subjects with a history of another primary malignancy other than: a. In situ carcinomas (e.g., breast, cervix and prostate) b. Locally excised non-melanoma skin cancer c. No evidence of the disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years. Exceptions are gonadotropin-releasing hormone (GnRH) therapy for prostate cancer and hormonal maintenance therapy for breast cancer, Presence of an active infection requiring IV antibiotics, Presence of a known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that might interfere with metabolism, Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV). In subjects with a history of HBV, hepatitis B core antibody (HBcAb) testing is required and if positive, HBV DNA testing will be performed and if positive, the subject will be excluded. For subjects with HCV Ab positive, HCV viral load must be below the limit of quantification, Chemotherapy, biological therapy, targeted therapy, immunotherapy, extended-field radiotherapy or investigational agents within 5 half-lives or 3 weeks (whichever is shorter), prior administering the first dose of study drug on Day 1 or in those who have not recovered from the side-effects of such therapy, Major surgery/surgical therapy for any cause within 4 weeks of the first dose
研究者
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