EUCTR2020-004569-37-ES进行中（未招募）1 期
ANV419 Single Agent (Parts A-C) or Combination (Part D) First in Human Study Phase 1/2: Open-label, Dose Escalation and Expansion Study in Patients with Relapsed/Refractory Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Anaveon AG
- 入组人数
- 75
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
- •Each patient must meet the following criteria to be enrolled in this study:
- •1.Ability of the patient or legal guardian to understand the purpose of the study, provide signed and dated informed consent from the patient prior to performing any protocol-related procedures (including Screening evaluations), and be able and willing to comply with the study procedures.
- •2.Male or female aged > or = 18 years.
- •3.Advanced solid tumors with evidence of progressive disease as per RECIST no longer than 3 months before ICF signature, without any subsequent curative intent treatment.
- •4.Parts A and B only: Histologically confirmed relapsed/refractory advanced solid tumor, progressing after at least one line of treatment for advanced or metastatic disease.
- •5.Parts C and D only: Histologically confirmed advanced metastatic melanoma or renal cell carcinoma, relapsed or refractory after at least one line of treatment for advanced disease. BRAF mutant melanoma must have progressed to BRAF + MEK inhibitor.
- •6.Parts C and D only: Radiologically measurable disease as per RECIST v1.1.
- •7.No additional established line of on-label treatment is available or there is a contraindication for the indicated labelled therapies.
- •8.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- •9.Adequate pulmonary, cardiovascular, hematological, liver and renal function, per Investigator judgment.
- •10.All acute toxic effects, of any prior anticancer therapy (e.g., radiotherapy, chemotherapy, or surgical procedures) must have resolved to CTCAE v5.0 grade =1 (except alopecia [any grade] or asthenia [up to grade 2 allowed]).
- •11.Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential and women <12 months after menopause.
- •12.For women who are not postmenopausal and have not undergone surgical sterilization: agreement to remain abstinent or use two adequate highly effective non-hormonal methods of contraception, including at least one method with a failure rate of <1 percent (%) per year, during the treatment period and until 6 months after the last dose of study treatment.
- •13.For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least for at least 6 months after the last dose of study treatment.
- •14.Availability and willingness of patients to obtain a baseline and on treatment biopsy of the tumor. Available archived biopsies (frozen or formalin fixed) may serve as baseline specimens, in patients who have residual tumor masses which can only be accessed with significant risk.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients who meet any of the following criteria will be excluded from the study:
- •1.Symptomatic central nervous system (CNS) metastases. Definitively treated CNS metastases (e.g., radiotherapy) stable for at least 6 weeks prior to Day 1 of study drug administration are acceptable.
- •2.Participants with an active second malignancy. Patients with precancerous lesions, concomitant early stages of prostate or breast cancer not requiring active treatment (past conditions currently resolved are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable.
- •3.Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosis. Stable vitiligo, autoimmune thyroiditis, and preexisting treated type 1 diabetes are acceptable and are not exclusion criteria.
- •4.Significant cardiovascular/cerebrovascular disease, including myocardial infarction (MI) or Transient Ischemic Attack TIA within 6 months prior to Day 1 of study drug administration.
- •5.Active or uncontrolled infections requiring systemic antibiotics within one week (7 days) preceding Day 1 of treatment.
- •6.Hemoglobin (Hb) <9 g/dL, transfusion of RBC allowed to reach threshold target
- •7.Neutrophils <1500 /mm3.
- •8.Platelets (PLTs) <75000/mm3.
- •9.Liver: AST and ALT >2.5 ULN, total bilirubin > 1.5 ULN (in documented Gilbert’s syndrome > 3mg/dl) however, if caused by liver metastasis as judged by the Investigator and Sponsor AST and ALT >5x ULN.
- •10.International normalized ratio (INR) >1.5x ULN.
- •11.Serum creatinine < 1.5 mg/dL and a measured creatinine clearance = 50 mL/min using the Cockcroft-Gault formula (Appendix 11.4).
- •12.Known replicating human immunodeficiency virus (HIV) or known active (replicative) hepatitis B virus or hepatitis C virus infection. Patients with treated non-replicative disease are acceptable.
- •13.Positivity for coronavirus disease 2019 (COVID-19) by naso-pharyngeal swab test. Known serologic conversion is not an exclusion criterion.
- •14.Evidence of hepatic cirrhosis with Child-Pugh score C.
- •15.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
- •16.Major surgery or significant traumatic injury <28 days prior to the first ANV419 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.
- •17.Severe altered mental status.
- •18.Pregnant or breastfeeding women.
- •19.Known hypersensitivity to any of the components of ANV419 or its formulation.
- •20.Concurrent therapy with any other investigational drug within one month prior to Day 1 of study drug administration.
- •21.Active untreated Immune-related endocrinopathies.
- •22.Chronic treatment with systemic immunosuppressive medications above 10mg/d Prednisolone equivalent.
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