NCT03382340进行中（未招募）1 期
A Phase 1/2a Open-Label, Dose-Escalation/Dose-Expansion Safety, Tolerability and Pharmacokinetic Study of IMX-110 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03.
研究概览
简要总结
Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110. The RP2D will be evaluated in a further dose expansion Phase 2a study submitted.
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
- •Male or female patients who are 18 years or older
- •Patients with confirmed advanced solid tumor as per histology, who have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type
- •Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (Appendix 2)
- •Patients with a life expectancy of at least 3 months
- •Patients with adequate cardiac function as measured by left ventricular ejection fraction >50%
- •Patients who meet the following laboratory requirements:
- •Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
- •Hemoglobin (HGB) ≥ 90.0 g/L (patients may be transfused to achieve this HGB level)
- •Platelet count ≥ 100 x 10^9/L
- •Total bilirubin level ≤ 1.5 x ULN
- •AST and ALT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis present)
- •Creatinine ≤ 1.5 x ULN (Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal)
- •Women of childbearing potential and men must agree to use highly effective, double barrier contraception during the study and for 6 weeks following the final dose of IMX-
- •Double barrier contraception is defined as a condom AND one other form of the following:
- •Birth control pills (The Pill)
- •Depot or injectable birth control
- •IUD (Intrauterine Device)
- •Birth control patch (e.g. Ortho Evra)
- •Documented evidence of surgical sterilization at least 6 months prior to the screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men.
- •Male patients must not donate sperm for at least 24 weeks post-dose of the last study treatment. Male partners of female patients and female partners of male patients must also use contraception, if they are of childbearing potential.
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -
- •Rhythm methods during the study and for 6 weeks after the dose of IMX-110 will not be acceptable.
排除标准
- •Patients with a history of severe allergic reactions to any unknown allergens or any components of the study drug formulation.
- •Patients receiving any chemotherapy within 14 days of dosing, immunotherapy within 28 days of dosing, or biologic or hormonal therapy within 28 days of dosing for cancer treatment. Patients with prostate cancer can continue administration of Gonadotropin-releasing hormone (GnRH) agonists.
- •Subject participating in any other drug study ≤ 4 weeks (6 weeks for immunotherapy investigational agents) or 5 half-lives of the investigational product, whichever is longer, prior to study drug administration or is scheduled to receive one during the treatment or post-treatment period.
- •Patients who have reached their life time limit of DOX or who are anticipated to reach their lifetime limit (550 mg/m2) within the first 2 cycles of IMX-110 administration.
- •Patients who are expected to need surgery or benefit from other anti-cancer therapy to be initiated during the study period.
- •Patients with a history of and/or risk factors for ischemic heart disease, congestive heart failure, symptomatic bradycardia, atrioventricular (AV) block, prolonged QTcF interval (>450 msec in men and >470 msec in women and additional risk factors for QT prolongation (e.g. hyperthyroidism, electrolyte imbalance).
- •Patients who have not recovered from adverse events (AEs; ≥ CTCAE grade 2) due to prior treatment (i.e. chemotherapy, targeted therapy, radiation, or surgery) within 7 days prior to Cycle 1 Day 1, unless deemed to be irreversible, or approved by the Sponsor and Medical Monitor.
- •Females who are pregnant or lactating or intend to become pregnant before, during, or within 24 weeks after participating in this study; or intending to donate ova during such time period.
- •Patients with a known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV). Patients may be enrolled if they have HBV or HCV with viral load suppressed by anti-virals.
- •Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
研究组 & 干预措施
Imx-110
Experimental
干预措施: Imx-110 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events assessed by CTCAE v4.03.
时间窗: 28 days
Maximum tolerated dose (MTD) of IMX-110 in patients with advanced solid tumors for evaluation in Phase 2a.
时间窗: 28 days
The MTD is defined as the highest dose at which ≤ 33% of the patients treated during the 3+3 design experience a DLT and/or at least two ≥ grade 2 toxicities during the first treatment cycle, and will be used to identify the RP2D to be taken forward to Phase 2a.
Recommended Phase 2 Dose (RP2D) of IMX-110 in patients with advanced solid tumors
时间窗: 28 days
RP2D is defined as one dose level below MTD
次要结局
- Plasma concentrations of IMX-110(5 days)
- Duration of Response (DOR)(5 years)
- Overall Survival (OS)(5 years)
- Response Rate(8 weeks)
- Progression-free survival (PFS)(5 years)
研究者
研究点 (2)
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