EUCTR2017-000625-12-NL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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 563
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 active metastatic or locally
- •advanced unresectable solid tumor in subjects 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:
- •Eligible indications, by Part:
- •Part A: BC, CRPC, NSCLC (including adenocarcinoma and squamous cell
- •subtypes), OEC, EC, HNSCC, and CCC;
- •Part A2: BC, NSCLC (including adenocarcinoma and squamous cell
- •subtypes), OEC,EC, and HNSCC;
- •Parts B, C2, and D2: TNBC, hormone receptor (HR; ie, estrogen and/or
- •progesterone)-positive/HER2-negative BC, NSCLC (including
- •adenocarcinoma and squamous cell subtypes), OEC, and HNSCC; and
- •Parts A mTPI-2 cohort, C1, and D1: BC, NSCLC (including
- •adenocarcinoma and squamous cell subtypes), and HNSCC;
- •Criterion specific to Parts B, C, and D:
- •Subjects must have received the standard prior treatments for
- •metastatic or advanced unresectable disease as outlined below, but not
- •more than 3 (=3) prior lines in total;
- •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 required for dose escalation (Part A)
- •and measurable disease per RECIST v1.1 required for Parts A2, B, C1, C2,
- •4. Subjects with treated brain metastases are eligible if the brain
- •metastases are stable and the subject does not require radiation
- •therapy, or steroids. Active screening for brain metastases (eg, brain
- •computed tomography or magnetic resonance imaging) is not required;
- •5. At least 18 years 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 for subjects with CCC and liver metastases); and serum
- •total bilirubin <= 1.5x institutional ULN (total bilirubin must be <=3x
- •institution's ULN in subjects with Gilbert's syndrome). Serum total
- •bilirubin <= 3.0 x institutional ULN for subjects with CCC and liver
- •For Parts B, C, D only: Hemoglobin >= 9.0 g/dL (without transfusion
- •within 30 days of Cycle 1
- •Day 1); AST, ALT, and alkaline phosphatase (ALP) <=2.5 × institution's
- •ULN (without exemption for liver or bone metastases); International
- •normalized ratio (INR) and activated partial thromboplastin time
- •(aPTT) <= 1.5 × ULN (unless subject is on therapeutic anticoagulation,
- •at which time the INR and aPTT must be in the target therapeutic
- •anticoagulation range); and Serum albumin >=2.5 g/dL.
- 另有 6 项未显示
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 antibiotic, antiviral or antifungal therapy within 2 weeks of study enrollment
- •- history of or current active autoimmune diseases, including but not limited to myasthenia gravis, inflammatory bowel diseases, RA, autoimmune thyroiditis which is not a sequela of prior immune checkpoint therapy, 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 EGFR or ALK 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 mAb 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
研究者
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