EUCTR2018-001456-34-GB进行中（未招募）1 期
A Phase 1-2, First-in-Human Study of CX-2029 in Adults withMetastatic or Locally Advanced Unresectable Solid Tumors orDiffuse Large B-cell Lymphomas - PROCLAIM-CX-2029
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
- •Inclusion Criteria for All Study Parts (Parts A, B, and C):
- •1. At least 18 years old
- •2. Ability to understand and willingness to sign a written informed consent form (ICF)
- •3. Screening laboratory values must meet the following criteria:
- •- Absolute neutrophil count =1500/µL
- •- Platelet count =100 × 10^3/µL (no transfusion within 2 weeks)
- •- Haemoglobin =10.0 g/dL (no transfusion within 2 weeks)
- •- Creatinine =1.5 × institution’s upper limit of normal (ULN)
- •- Both aspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT) =2.5 x institution's ULN; for subjects with liver metastases, AST
- •and ALT =5 x institution's ULN
- •- Total bilirubin =1.5 × ULN (total bilirubin must be =3 × institution’s ULN in subjects with Gilbert’s syndrome)
- •4. Subjects with treated brain metastases (surgery, stereotactic
- •radiation, whole brain radiation or a combination of these modalities)
- •are eligible if the subject's brain metastases have been documented to
- •be are stable by head imaging (two scans at least 28 days apart, including the scan obtained during the screening period) and the screening clinical examination is stable and the subject does not require radiation therapy or high-dose steroids (prednisone of 10 mg/day or equivalent). Active screening for brain metastases (e.g., brain computed tomography or magnetic resonance imaging) is not required
- •5. Subjects with NSCLC (Part A: any histology; Parts B and C: squamous
- •histology): o Must have received prior treatment with platinum-based therapy
- •(unless intolerant or not suitable) and a PD-1/PD-L1 inhibitor. A
- •checkpoint inhibitor should have been administered if approved for the
- •subject's indication in their locality, alone or in combination with other
- •o Subjects with non-squamous cell histology must have undergone
- •specific genomic testing performed (epidermal growth factor receptor
- •[EGFR], anaplastic lymphoma kinase [ALK], ROS1, B-RAF)
- •o Subjects with squamous cell histology are not required to have specific
- •genomic testing performed (such as EGFR, ALK, ROS1, B-RAF, Kirsten rat
- •sarcoma [KRAS], MET, RET, and neurotrophic-tropomyosin receptor
- •kinase [NTRK]); testing may be performed but is not required. If a
- •subject is known to carry a genetic mutation or translocation, the
- •subject should have received the appropriate targeted therapy and
- •progressed or shown intolerance to the therapy prior to enrollment in this protocol
- •o Subjects with advanced or metastatic stage IV NSCLC with known
- •EGFR or ALK genomic alterations are eligible if they have progressed on
- •treatment or did not tolerate appropriate targeted therapy. This would
- •include osimertinib for T790M mutation-positive NSCLC.
- •o Subjects with known NSCLC with known ROS1 rearrangement must
- •have received prior treatment with crizotinib
- •o Subjects with known B-RAF mutations must have received prior
- •treatment with a B RAF inhibitor
- •6. Females of childbearing potential and non-sterile males must agree to
- •practice highly effective methods of birth control (as described in
- •Appendix E) for the duration of the study and for 6 months after the last
- •dose of study drug. In addition, non-sterile 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 after the last dose of CX-2029
- •and to avoid sperm donation for the duration of the study and for 6
- •months after the last dose of study drug.
- •Inclusion Criteria Specific for Part A, P
排除标准
- •1. Neuropathy >Grade 1
- •2. Serious concurrent illness, including, but not limited to, the following:
- •- Clinically-relevant infection, including known active hepatitis B or C, human immunodeficiency virus, or non-viral infection requiring antibiotics
- •- Significant cardiac disease, such as recent myocardial infarction (=6 months prior to Cycle 1 Day 1), unstable angina pectoris, uncontrolled congestive heart failure (New York Heart Association >Class II), uncontrolled diabetes (hemoglobin A1c [HbA1c] >7%) uncontrolled hypertension (NCI CTCAE Version 5.0 Grade 3 or higher), uncontrolled cardiac arrhythmias, severe aortic stenosis, or =Grade 3 cardiac toxicity following prior chemotherapy
- •- History of hemorrhagic or ischemic stroke within the last 6 months, or clinically significant alcoholic liver disease
- •- History of or current active autoimmune diseases, including but not
- •limited to 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
- •- History of or current active autoimmune diseases, including but not
- •limited to 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
- •- History of or current active autoimmune diseases, including but not limited to 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
- •- 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
- •- Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
- •- Severe renal impairment (creatinine clearance [CrCl] <30 mL/min)
- •3. Any prohibited medications as described in the protocol including but
- •not limited to: Chemotherapy, non-biological anticancer therapies and
- •radiotherapy within 14 days prior to Cycle 1 Day 1; biologics
- •(monoclonal antibodies) require a 30 -day interval prior to receiving the
- •first dose of study drug
- •4. History of severe allergy or anaphylactic reaction to previous monoclonal antibodies or known hypersensitivity to auristatins
- •5. Unresolved acute toxicity NCI CTCAE Version 5.0 >Grade 1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other non-acute toxicities are acceptable
- •6. History of malignancy within the previous 2 years except for localized basal cell or squamous cell skin cancers, superficial bladder cancers, or carcinoma in situ of the prostate, cervix, or breast
- •7. Concurrent anticoagulation with warfarin
- •8. Inability to discontinue treatment with a strong CYP3A4 inhibitor or strong CYP3A4 inducer prior to start of treatment
- •9. Clinically significant iron metabolism disorders (eg, sickle cell anemia)
- •10. Transfusion dependent anaemia with transfusion of at least
研究者
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