EUCTR2022-002169-14-ES进行中（未招募）1 期
A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
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
- •Each patient must meet all the following criteria to be enrolled in the study:
- •1. Patients aged 18 years or older.
- •2. Documented multiple myeloma (MM) diagnosis per International Myeloma Working Group (IMWG) criteria.
- •3. Measurable disease, defined as at least 1 of the following:
- •a. Serum M protein =0.5 g/dL (=5 g/L) on serum protein electrophoresis (SPEP).
- •b. Urine M protein =200 mg/24 hours on urine protein electrophoresis (UPEP).
- •c. Serum free light chain (FLC) assay with involved FLC level =10 mg/dL (=100 mg/L) provided serum FLC ratio is abnormal.
- •4. For patients in the phase 1 dose escalation only:
- •Must have received at least 3 prior lines of therapy, including at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb drug; or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug, regardless of the number of prior line(s) or therapy.
- •5. For patients in phase 2a dose finding only:
- •a. Received 1 to 3 prior line(s) of antimyeloma therapy.
- •b. Must be refractory to prior lenalidomide treatment.
- •c. Patients must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment.
- •d. Documented progressive disease on or after the last regimen.
- •e. Patients must have PR or better to at least 1 line of prior therapy...
- •Please see Protocol Section 7.1 for full inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Patients meeting any of the following criteria are not to be enrolled in the study:
- •1. Prior exposure to modakafusp alfa.
- •2. Patient has POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma.
- •3. Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade =1 or baseline, except for alopecia.
- •4. Previous allogeneic stem cell transplant at any time or ASCT within 12 weeks of planned start of dosing.
- •5.Another malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapy and that in the opinion of the local investigator, with concurrence with the sponsor, is considered to have minimal risk of recurrence within 3 years.
- •Please see Protocol Section 7.2 for full exclusion criteria.
研究者
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