EUCTR2021-006038-37-IE进行中（未招募）1 期
A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma - A Safety and Preliminary Efficacy, Pharmacokinetics, and Immunogenicity Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 236
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
- 性别
- All
入选标准
- •For Parts 1 and 2:
- •1. MM defined by the IMWG criteria with evidence of disease progression and:
- •a) Is in need of additional myeloma therapy as determined by the investigator.
- •b) Has previously received at least 3 lines of myeloma therapy (eg, containing an IMiD, a PI, an alkylating agent, and/or an anti-CD38 as single agents or in combination).
- •c) Is either refractory to, or intolerant of, at least 1 PI and at least 1 IMiD (see NOTE below).
- •For Part 3:
- •1. MM defined by the IMWG criteria with evidence of disease progression and:
- •a) Is in need of additional myeloma therapy as determined by the investigator.
- •b) Has previously received at least 3 lines of myeloma therapy.
- •c) Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and who have demonstrated disease progression with the last therapy (see NOTE below). Patients who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible.
- •NOTE: Refractory is defined as ?25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment.
- •A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease (Rajkumar et al. 2011).
- •2. Aged 18 years or older.
- •3. For patients in Parts 2 and 3 only: Measurable disease defined as one of the following:
- •a) Serum M-protein =500 mg/dL (=5 g/L).
- •b) Urine M-protein =200 mg/24 hours.
- •c) Serum free light chain (FLC) assay with involved FLC level =10 mg/dL (=100 mg/L) provided serum FLC ratio is abnormal.
- •4. During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (=10%) and/or plasmacytoma (=1 cm in diameter) detected by physical examination or imaging.
- •5. ECOG performance status of =2.
- •6. Patient has adequate organ function as determined by the following laboratory values. See Protocol for values.
- •7. Patient has received the final dose of any of the following treatments/procedures within the specified minimum intervals before the first dose of modakafusp alfa. See Protocol for values.
- •8. Female patients who:
- •Are postmenopausal for at least 2 years before the screening visit, OR
- •Are surgically sterile, OR
- •If they are of childbearing potential:
- •– Agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, OR
- •– Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject, from the time of signing the informed consent through 6 months after the last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, an
排除标准
- •1. Patient has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia or IgM myeloma, or lymphoplasmacytic lymphoma.
- •2. Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
- •3. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
- •4. Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa. For patients who have received less than 5 months of daratumumab or who have received another anti-CD38 monoclonal antibody, the necessary wash-out period needs to be discussed and approved by the sponsor. Once the MTD/OBD has been confirmed, these patients can be enrolled in the trial (Parts 2 and 3).
- •Parts 2 and 3: No washout from daratumumab or isatuximab is required.
- •5. Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade =1 or baseline, except for sensory or motor neuropathy which should have recovered to Grade =2 or baseline.
- •6. Patient has congestive heart failure (New York Heart Association Grade =II), cardiac
- •myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina
- •pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or
- •clinically significant uncontrolled hypertension.
- •7. Patient has a history of acute myocardial infarction within 5 months from enrollment or has
- •ECG abnormalities during screening that are deemed medically relevant by the investigator.
- •8. Patient has QT interval corrected by the Fridericia method (QTcF) >480 msec (Grade =2).
- •9. Patient has a concurrent illness that would preclude study conduct and assessment including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life-threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease, pulmonary fibrosis, and history of symptomatic bronchospasm), alcoholic liver disease, or primary biliary cirrhosis.
- •10. Patient has a chronic condition requiring the use of systemic corticosteroids >10 mg/day of
- •prednisone or equivalent.
- •11. Patient has clinical signs of central nervous system involvement of MM.
- •12. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug if applicable.
- •13. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
- •14. Patient has a known history of human immunodeficiency virus.
- •15. Parts 1 and 2: Known chronic hepatitis C and/or positive serology (unless due to vaccination or
- •passive immunization due to Ig therapy) for chronic hepatitis B.
- •Part 3: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [
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