NCT04984434Unknown1 期
A First-in-human, Open-label, Multiple Center Phase 1 Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy of F182112 in Patients With Relapsed or Refractory Multiple Myeloma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of F182112 when infused IV.
详细描述
To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of F182112 as monotherapy in patients with relapsed or refractory multiple myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures;
- •Male or female ≥ 18 years;
- •Patient has a history of multiple myeloma with relapsed and refractory disease, and must:
- •Relapsed after an autologous stem cell transplant (ASCT), or not suitable for ASCT;
- •Must have received at least 2 prior multiple myeloma treatment regimens (not including autologous stem cell transplant) including a proteasome inhibitor, an immunomodulatory agent;
- •ECOG of 0-2;
- •Patients must have measurable disease, including at least one of the criteria below:
- •M-protein ≥ 0.5 g/dL by SPEP/immunofixation or
- •≥ 200 mg/24 hours urine collection by UPEP or
- •Serum free light chain (FLC) levels > 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M-protein;
- •Adequate hepatic function as evidenced by meeting all the following requirements:
- •Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109/L, hemoglobin (Hb) ≥70g/L, Platelet ≥ 50×109/L;
- •Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN, Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- •Renal function: calculated creatinine clearance (CrCL) ≥ 30 mL/min (Cockroft-Gault Equation).
- •Recovery to Grade 0-1 from adverse events related to prior anticancer therapy except alopecia, ≤ Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement therapy.
排除标准
- •Patient has primary light chain amyloidosis or plasma cell leukemia;
- •Patient has symptomatic central nervous system involvement of multiple myeloma;
- •Received systemic anti-myeloma therapy within 2 weeks, or received plasma exchange within 4 weeks;
- •Received any experimental drugs within 4 weeks or 5 half-lives (whichever is shorter);
- •Patient has received ≥ 40 mg/day dexamethasone equivalent within 7 days before starting F
- •Short term use of corticosteroids at doses equivalent to > 10 mg/d of prednisone；
- •Received any monoclonal antibody therapy within 30 days;
- •Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;
- •Patient had a prior allogeneic stem cell transplant or had a prior autologous stem cell transplant ≤ 3 months prior to starting F182112;
- •Live virus vaccine within 30 days prior to study entry;
- •Major surgery within 4 weeks prior to study entry;
- •Concurrent malignancy within 3 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma;
- •Patients with active mucosa or visceral bleeding;
- •Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry. Patients with a rate-controlled arrhythmia may be eligible for study entry at the discretion of the Medical Monitor;
- •Active infection requiring antibiotic, antiviral or antifungul therapy;
- •Active viral hepatitis;
- •Has a history of immunodeficiency, include HIV infection;
- •Treponema pallidum infection;
- •Received any experimental drugs or anti-tumor drugs within 2 weeks;
- •Subject has any condition that confounds the ability to interpret data from the study;
- •Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and 6 months after the last giving F182112;
- •Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
研究组 & 干预措施
Experimental: Single Arm
Experimental
干预措施: F182112 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Approximately 12 months
Maximum Tolerated Dose
RP2D
时间窗: Approximately 12 months
Preliminary Antitumor Activity of F182112 at the RP2D(s) in Part 2
DLTs
时间窗: Up to 28 days
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
次要结局
- Overall survival (OS)(Approximately 24 months)
- Objective response rate (ORR)(Approximately 24 months)
- Progression-free survival (PFS)(Approximately 24 months)
研究者
研究点 (1)
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