CTRI/2024/04/065308招募中1 期
A Phase 1/2, First-in-Human, Multicentre, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma - NI
试验速览
- 阶段
- 1 期
- 状态
- 招募中
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
入选标准
- •1. Male or female patients aged 18 years or older.
- •2. Be willing and able to provide written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act of 1996 [HIPAA]) prior to any protocol related procedures, including screening evaluations
- •3. Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients):
- •a) Must have received PIs, IMiDs, and anti-CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefits.
- •b) Must have measurable M-protein (serum and/or 24-hour urine, or serum free light chains).
- •4. Phase 2a: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients):
- •Cohort A: R/R MM
- •a) Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
- •Serum M-protein = 0.5 g/dL (IgA = 0.5 g/dL), or
- •Urine light-chain (M-protein) of = 200 mg/24 hours, or
- •Serum free light chain (sFLC) assay: involved free light chain (FLC) level = 10 mg/dL provided sFLC ratio is abnormal.
- •Cohort B: R/R MM Post-T-Cell Directed Therapy
- •a) Must have received PIs, IMiDs, and anti-CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefits.
- •b) Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
- •Serum M-protein = 0.5 g/dL (IgA = 0.5 g/dL), or
- •Urine light-chain (M-protein) of = 200 mg/24 hours, or
- •sFLC assay: involved FLC level = 10 mg/dL provided sFLC ratio is abnormal
- •5. Have a body weight = 40.0 kg at screening.
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- •7. Have life expectancy of at least 3 months (from date of informed consent signing).
- •8. Have adequate organ function, including:
- •a. Estimated creatinine clearance =45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine analysis.
- •b. Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) =3.0 × ULN; bilirubin =1.5 × ULN. Patients with Gilberts syndrome may have a bilirubin level greater than 1.5 times ULN, per discussion between the Investigator and medical monitor.
- •9. Left ventricular ejection fraction (LVEF) =45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan.
排除标准
- •1. Patients with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
- •2. Participants with MM with disease where the only measurable parameter is plasmacytoma. Note: Prophylactic localized (spot) radiation for areas of pain is allowed
- •3. Received treatment with anti-CD38 antibodies or CD47 targeted therapies within 28 days of C1D1; systemic anticancer treatments within 14 days of (C1D1) or any investigational products within 5 half-lives of C1D1. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 mg/day for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-? ligand inhibitors are allowed.
- •4. Received autologous stem cell transplantation within 12 weeks of C1D1.
- •5. Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
- •6. Active malignant central nervous system involvement
- •7. Known to be refractory to platelet or RBC transfusions
- •8. Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation.
- •9. Prior radiation therapy within 14 days of C1D1 or prior irradiation to greater than 25% of the bone marrow. Note: Prophylactic localized (spot) radiation for areas of pain is allowed.
- •10. QTc interval greater than 480 msec at screening using Fredericias QT correction formula.
研究者
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