NL-OMON48575已完成2 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Subjects who fulfill the following criteria at Screening will be eligible for
- •admission into the
- •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 the following
- •indications (with guidance for standard treatment below).
- •For Parts A2, B, C1, C2, D1, and D2, an archival tumor tissue sample must be
- •submitted to
- •the central laboratory for evaluation of CD166 expression and demonstrate
- •confirmed high
- •CD166 expression by IHC. Biopsy collection for the purpose of determining
- •eligibility is not
- •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
- •unresectable disease as outlined below, but not more than 3 (<=3) prior lines in
- •Standard prior treatments, by tumor type:
- •BC (Parts A, A2, C1, and D1):
- •* Patients with HER2-positive BC are required to have progressed on
- •HER2-targeted
- •therapy (trastuzumab, pertuzumab, and/or T-DM1);
- •* Estrogen-receptor-positive should have received anti-hormonal therapy, a
- •inhibitor, or mTOR inhibitor and progressed; and
- •* TNBC should have received at least 2 prior lines of therapy;
- •TNBC (Parts B, C2, and D2):
- •* Should have received at least 2 prior lines of therapy; and
- •* Subjects with BReast CAncer gene (BRCA) mutations must be refractory to or
- •otherwise ineligible for poly adenosine diphosphate-ribose polymerase
- •inhibitors (eg,
- •olaparib), if approved and available;
- •HR-positive/HER2-negative BC (Parts B, C2, and D2):
- •* Should have received and progressed on an anti-hormonal therapy, targeted
- •(CDK4/6 or mTOR inhibitor), or chemotherapy;
- •* Endocrine refractory should have received at least 3 prior hormonal therapies
- •progressed;
- •* Post or pre-menopausal subjects receiving ovarian ablation or suppression
- •progressed on an aromatase inhibitor (AI) in combination with a CDK4/6
- •inhibitor or
- 另有 13 项未显示
排除标准
- •Subjects who fulfill any of the following criteria at Screening will not be
- •eligible for admission:
- •1. Neuropathy >Grade 1;
- •2. Active or chronic corneal disorder, including but not limited to the
- •following: Sjogren's syndrome, Fuchs corneal dystrophy (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, presence of papilledema, and acquired
- •monocular vision;
- •3. Serious concurrent illness, including, but not limited to the following:
- •Clinically relevant active infection including known active hepatitis B or
- •C, human immunodeficiency virus infection, or cytomegalovirus 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, rheumatoid
- •arthritis, 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
- •insulin dependent diabetes mellitus;
- •Significant cardiac disease such as recent myocardial infarction (£6
- •months prior to
- •Day 1), unstable angina pectoris, uncontrolled congestive heart failure (New
- •York Heart Association >class II), uncontrolled hypertension (NCI CTCAE v4.03
- •Grade 3 or higher), uncontrolled cardiac arrhythmias, severe aortic stenosis,
- •or ³Grade 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
- •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 anticancer 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 ³30 days are permitted
- •for subjects with
- •6. History of severe allergic or anaphylactic reactions to previous mAb
- •7. Prior treatment with maytansinoid-containing drug conjugates (eg, Kadcyla
- •[T-DM1]);
- •8. Subjects with a previously documented absence of thiol-S-purine
- •methyltransferase activity;
- 另有 5 项未显示
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