CTIS2023-508727-12-00招募中1 期
A Phase 1/2 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and Refractory Multiple Myeloma - CC-92480-MM-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 158
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
- •Subject is = 18 years of age at the time of signing the informed consent form (ICF)., Males must agree to refrain from donating sperm while on CC-92480 for 94 days after the last dose of CC-92480. Females must agree to refrain from donating ova while on CC-92480 for 184 days after last dose., All subjects must agree to refrain from donating blood while on CC- 92480 and for 28 days after its discontinuation., Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted., Subject is willing and able to adhere to the study visit schedule and other protocol requirements., Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2., Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as: a. M-protein quantities = 0.5 g/dL by sPEP or b. = 200 mg/24 hour urine collection by uPEP or c. Serum FLC levels > 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda (?/?) ratio in subjects without measurable serum or urine M-protein or d. for subjects with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level = 0.50 g/dL, All subjects must have: a. received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen), b. documented disease progression on or within 60 days from the last dose of their last myeloma therapy, i. subjects who had CAR-T therapy as their last myeloma therapyare eligible as long as they have documented disease progression following CAR-T therapy, c. in addition to criteria above (a and b), subjects enrolled in Part 2, must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose., Subjects must have the following laboratory values: a. Absolute neutrophil count (ANC) = 1.25 x 10 to the power 9 /L without growth factor support for = 7 days (= 14 days for pegfilgrastim). ANC of = 1.00 x 109/L is permitted for the dose expansion cohorts (Part 2). b. Hemoglobin (Hgb) = 8 g/dL. c. Platelets (plt) = 75 x 10 to the power 9 /L without transfusion for = 7 days (= 50 x 10 to the power 9 /L for subjects with > 50% plasma cells in bone marrow). d. Corrected serum calcium = 13.5 mg/dL (= 3.4 mmol/L). e. Creatinine clearance (CrCl) based on Cockcroft-Gault formula = 45 mL/min. f. AST/SGOT and ALT/SGPT = 3.0 x upper limit of normal (ULN). g. Serum bilirubin = 1.5 x ULN or < 3.0 mg/dL for subjects with documented Gilbert's syndrome. h. Uric acid = 7.5 mg/dL (446 µmol/L). i. PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation)., Females of childbearing potential (FCBP) must: a. Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after discontinuation of CC- 92480. This applies even if the subject
排除标准
- •Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study., Subject is undergoing dialysis., Subjects with peripheral neuropathy = Grade 2., Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480., Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following: • LVEF < 45% as determined by ECHO or MUGA scan at Screening. • Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic (ECG) finding at Screening. • A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval >480 milliseconds (ms) using Fridericia's QT correction formula; a history of or current risk factors for Torsades de Pointe (eg. heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval. • Congestive heart failure (New York Heart Association Class III or IV). • Myocardial infarction =6 months prior to starting CC-92480. • Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris., Concurrent administration of strong CYP3A modulators; concurrent administration of proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) = 2 weeks prior to starting CC-92480, Subject had prior systemic myeloma treatment with an investigational anti-myeloma agent (eg, anti-PD-1, anti-PD-L1) = 5 halflives prior to starting CC-92480 (not applicable for subjects who had CAR-T as last prior regimen); Subject had prior systemic myeloma treatment with an investigational agent (eg. anti-PD-1, anti-PD-L1) = 5 half-lives prior to starting CC-92480; or subject had prior exposure to approved myeloma therapies (including therapeutic monoclonal antibodies such as anti-CD38 or anti-SLAM-7) =5 half-lives or within 4 weeks prior to starting CC-92480 whichever is shorter., Subject had major surgery = 2 weeks prior to starting CC-92480. Note: Subjects must have recovered from any clinically significant effects of recent surgery., Subject is a pregnant or nursing female, or intends to become pregnant or donate ova during participation in the study., Subject has known human immunodeficiency virus (HIV) infection., Subject has known active chronic hepatitis B or C virus (HBV/HCV) infection., Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study., Subject has a history of concurrent second cancer requiring ongoing systemic treatment., Subjects has a history of prior malignancy other than MM, except if the subject has been free of disease for =3 years OR the subject had one of the following noninvasive malignancies treated with curative intent without known recurrence: • Basal or squamous cell carcinoma of the skin. • Carcinoma in situ of the cervix or breast. • Stage 1 bladder cancer. • Incidental histological findings of localized prostate cancer such as tumor stage 1a or 1b (T1a or T1b) using the Tumor/Node/Metastasis (TNM) classification of malignant tumors OR prostate cancer that has been treated with curative intent., Subject has a history of anaphylaxis to thalidomide, lenalidomide, pomalidomide or dexamethasone., Subject has known or suspected hypersensitivity to the
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