EUCTR2017-000625-12-ES进行中（未招募）1 期
A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009) - PROCLAIM-CX-2009
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •1. Histologically confirmed diagnosis of any active metastatic or locally advanced unresectable solid tumor. Subjects with advanced or metastatic solid tumors who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment in following indications: breast carcinoma, castration-resistant prostate cancer, non-small cell lung cancer (incl adenocarcinoma and squamous cell subtypes), overian carcinoma, endometrial carcinoma, head and neck squamous cell carcinoma, cholangiocarcinoma
- •2. Agrees to provide tumor tissue, archival, new or recent acquisition confirmed to be available prior to initiation of study drug for performance of correlative tissue and cellular studies from a tumor site not previously irradiated
- •3. Evaluable or measurable disease for dose escalation part A and measurable disease required for dose expansion cohorts part B
- •4. Subjects with treated brain metastases are eligible if brain metastases are stable and subject does not require radiation therapy or steroids. Active screening for brain metastases is not required.
- •5. At least 18 y of age
- •6. Eastern Cooperative Oncology Group performance status of 0 or 1
- •7. Anticipated life expectancy of at least 3 months
- •8. screening lab values must meet following criteria: absolute neutrophil count >=1500µl; platelet count >= 100 x 10³/µl (must not have been transfused within prev. 10 days); hemoglobin >=9.0 g/dL (may have been transfused); serum creatinine <= 1.5 x institution upper limit of normal (ULN); aspartate aminotransferase (AST) <= 2.5xinstitution's ULN; alanine aminotransferase (ALT) <= 2.5x institution's ULN (AST, ALT <5 x ULN if liver metastases); and serum total bilirubin <= 1.5x institutional ULN (total bilirubin must be <=3x institution's ULN in subjects with Gilbert's syndrome)
- •9. Women of childbearing potential and males must agree to use a highly effective method of contraception prior to study entry, while on study drug and for a period of 50 days following the last treatment; highly effective methods of contraception which result in a low failure rate (ie <1 % per year) when used consistently and correctly include implants, injectables, combined hormonal contraceptives, some IUD's, sexual abstinence or a vasectomized partner - True abstinence, when in line with the preferred and usual lifestyme of the subjects is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. (periodic abstinence and withdrawal are not acceptable methods of contraception)
- •10. The ability to understand and the willingness to sign a written informed consent document and adhere to study schedule and prohibitions
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Neuropathie > grade 1
- •2. Active chronic corneal disorder, including but not limited to the following: sjogren's syndrome, Fuchs corneal dystropathy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and also active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presensce of papilledema and acquired monocular vision
- •3. Serious concurrent illness, including, but not limited to following:
- •- clinically relevant active infection including known active hepatitis B or C. HIV infection or CMV infection or any other known concurrent infectious disease requiring IV antibiotics within 2 weeks of study enrollment
- •- history of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, RA, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies or type 1 insuline dependent diabetes mellitus
- •- significant cardiac disease such as recent MI (<= 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure (NY Heart association >class II), uncontrolled hypertension (NCI CTCAE v.4.03 grade 3 or higher), uncontrolled cardiac arrythmias, severe aortic stenosis or >= grade 3 cardiac toxicity following prior chemotherapy
- •- History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease
- •- Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm
- •- Psychiatric illness/social situations that would limit compliance with study requirements
- •- Interstitial lung disease irrespective of etiology
- •4. Advanced or metastatic Stage IV NSCLC subjects with epidermal growth factor receptor or anaplastic lymphoma kinase genomic alterations unless they have progressed on treatment with appropriate targeted therapy, including osimertinib for T790M mutation-positive NSCLC
- •5. Any other anti-cancer treatment such as chemotherapy, immunotherapy, biochemotherapy, radiotherapy, investigative therapy, or high-dose steroids within 30 days of receiving study drug. Low-dose steroids, luteinizing hormone-releasing hormone, aromatase inhibitors (eg, anastrozole), at doses that have been stable for 30 days are permitted for subjects with CRPC
- •6. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy
- •7. Prior treatment with maytansinoid-containing drug conjugates
- •8. Subjects with a previously documented absence of thiol-S-purine methyltransferase activity
- •9. Unresolved acute toxicity NCI CTCAE v4.03 Grade >1 (or baseline, whichever is greater) from prior anti-cancer therapy. Alopecia and other non-acute toxicities are acceptable
- •10. History of malignancy that is active within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered to have been cured and in the opinion of the Investigator, present a low risk for recurrence, including basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast
- •11. Currently receiving anticoagulation therapy with warfarin
- •12. The subject has undergone major surgery (requiring general anesthesia)
研究者
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