2024-517444-64-00招募中2 期
A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination with Standard of Care Therapy in Patients with Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia (BEXMAB Study)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 4
- 主要终点
- Phase I - 1. Reporting of incidence and frequency of dose limiting toxicities (DLTs), and frequency and severity of adverse events (AE), SAEs and laboratory abnormalities.
研究概览
简要总结
Phase I
- To determine the safety and tolerability of bexmarilimab in combination with SoC treatment to identify the recommended dose for expansion (RDE).
Phase II
- To evaluate the preliminary clinical efficacy of bexmarilimab at recommended phase 2 dose (RP2D) in combination with SoC.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient ≥ 18 years of age who presents with one of the following conditions: - Morphologically confirmed diagnosis of MDS with revised International Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very high. - Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine treatment. - CMML and MDS patient with response failure to HMA or therapy regimen including HMA. - Morphologically confirmed diagnosis of r/r AML following at least 1 line of prior therapies with indication for azacitidine treatment. - Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
- •Leukocyte count < 20 x10^9/L (< 25 x10^9/L for newly diagnosed AML). Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in CMML.
- •Adequate renal function.
- •Adequate liver function.
排除标准
- •Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count > 13 x10^9/L.
- •Eastern Cooperative Oncology Group (ECOG) performance status >2 (except newly diagnosed AML where ECOG 3 is allowed for patients < 75 years).
- •Allogeneic transplantation less than 6 months prior screening.
- •Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
- •The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment.
- •Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than 14 days or five half-lives (whichever is shorter) from a small molecule targeted therapy or oral anticancer chemotherapy before the first study treatment.
- •Any immunotherapy or investigational therapy within preceding 28 days from the first study treatment.
- •Pregnant or lactating women.
- •History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.
结局指标
主要结局
Phase I - 1. Reporting of incidence and frequency of dose limiting toxicities (DLTs), and frequency and severity of adverse events (AE), SAEs and laboratory abnormalities.
Phase I - 1. Reporting of incidence and frequency of dose limiting toxicities (DLTs), and frequency and severity of adverse events (AE), SAEs and laboratory abnormalities.
Phase II - 1. Preliminary efficacy will be investigated per indication as follows: - Complete response (CR) rate for MDS and CMML-2. - Overall response rate (ORR) for MDS and CMML failure to prior HMA. - CR for r/r AML. - CR rate for newly diagnosed AML.
Phase II - 1. Preliminary efficacy will be investigated per indication as follows: - Complete response (CR) rate for MDS and CMML-2. - Overall response rate (ORR) for MDS and CMML failure to prior HMA. - CR for r/r AML. - CR rate for newly diagnosed AML.
次要结局
- Phase I - 1. Clinical efficacy measures include disease-specific response criteria and progression and survival analyses.
- Phase I - 2. PK samples at defined timepoints of single and repeat bexmarilimab administration and derived PK parameters.
- Phase I - 3. Anti-bexmarilimab antibody detection.
- Phase II - 1. Frequency and severity based on NCI-CTCAE v 5.0 grading of adverse events (AE), SAE and laboratory abnormalities.
- Phase II - 2. Extended preliminary efficacy to include disease-specific response criteria and progression and survival analyses.
- Phase II - 3. Anti-bexmarilimab antibody (immunogenicity) detection.
研究者
Regulatory Affairs
Scientific
Faron Pharmaceuticals Oy
研究点 (4)
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