EUCTR2019-004706-10-BE进行中（未招募）1 期
A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
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
- 358
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Common Inclusion Criteria For All Groups/Cohorts/Combinations:
- •- Signed written informed consent.
- •- Male or female patients aged = 18 years.
- •- ECOG performance status of 0 to 1 at study entry.
- •- Disease must be measurable with at least 1 unidimensional measurable
- •lesion by RECIST 1.1. (Not applicable to Accelerated Titration and 3+3
- •Dose Escalation cohorts.
- •- Baseline LVEF = 55% measured by echocardiography (preferred) or
- •- Adequate hematological function defined by white blood cell (WBC)
- •count = 3 × 109/L with absolute neutrophil count (ANC) = 1.5 × 109/L,
- •lymphocyte count = 0.5 × 109/L, platelet count = 75 × 109/L (in Dose
- •Escalation, Safety/PK/PD, and Dose Expansion parts), platelet count =
- •100 × 109/L (in Efficacy Expansion part), and hemoglobin = 9 g/dL
- •(may have been transfused but must show hematologic count stability
- •for 14 days from the time of transfusion to C1D1).
- •- Adequate hepatic function defined by a total bilirubin level = 1.5 × the
- •upper limit of normal (ULN). Aspartate aminotransferase (AST) level =
- •2.5 × ULN, and an alanine aminotransferase (ALT) level = 2.5 × ULN or,
- •for patients with documented metastatic disease to the liver, AST and
- •ALT levels = 5 × ULN. Patients with known Gilbert Disease who have
- •serum bilirubin level = 3 ULN may be enrolled.
- •- Adequate renal function defined by an estimated creatinine clearance =
- •50 mL/min according to the Cockcroft-Gault formula or another
- •calculation of measurement method as according to local standards.
- •- Subjects must be willing to use appropriate contraception as defined in
- •the protocol.
- •- Effective contraception for women of childbearing potential (WOCBP)
- •and male patients as defined by World Health Organization (WHO)
- •guidelines for 1 highly effective method or 2 effective methods.
- •CTFG. WOCBP require use of a highly effective contraceptive measure.
- •Contraception methods with low user dependency should preferably be
- •used, in particular when contraception is introduced as a result of
- •participation in the clinical trial for 120 days after last dose.
- •A male subject should use condom during treatment and until the end of
- •relevant systemic exposure in the male subject plus a further 90-day
- •period. For a non-pregnant WOCBP partner, contraception
- •recommendations should also be considered.
- •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 318
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Exclusion Criteria for All Patients of Both Study Parts:
- •1. Previous treatment with drugs that specifically target the HER2 pathway (mAb or Tyrosine Kinase Inhibitor [TKI]) is acceptable providing washout period
- •2. Concurrent anticancer treatment, immune therapy, or cytokine therapy
- •3. Life expectancy of less than 3 months.
- •4. Active or history of central nervous system (CNS) metastases.
- •5. Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
- •6. Significant acute or chronic infections
- •7. Preexisting autoimmune disease needing treatment with systemic immunosuppressive agents = 28 days within the last 3 years or clinically relevant immunodeficiencies (e.g, dys-gammaglobulinemia or congenital immunodeficiencies), or fever Grade 2 or higher within 7 days of Day 1.Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.
- •8. Pregnancy or lactation in females during the study.
- •9. Serious cardiac illness or clinically relevant uncontrolled cardiac risk factors
研究者
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