EUCTR2018-001456-34-ES进行中（未招募）1 期
A Phase 1-2, First-in-Human Study of CX-2029 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas - PROCLAIM-CX-2029
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
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
入选标准
- •Inclusion Criteria for All Study Parts (Parts A, B, and C):
- •1. At least 18 years old
- •2. Ability and willingness to sign an 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)
- •- Hemoglobin =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 × 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 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. Subjects with NSCLC:
- •- Must have received prior treatment with platinum-based therapy 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 therapy
- •- Subjects with advanced or metastatic stage IV NSCLC with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (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
- •- Subjects with NSCLC with known ROS1 rearrangement must have received prior treatment with crizotinib
- •6. Females of childbearing potential and non-sterile males must agree to practice highly effective methods of birth control for the duration of the study and for 6 months after the last dose of study drug
- •Inclusion Criteria Specific for Part A, Part B, or Part C
- •1. Histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
- •2. Documented progression or relapse after at least 1 prior systemic therapy. Moreover, subjects must have exhausted available life prolonging therapies
- •3. Measurable or evaluable per RECIST v1.1
- •4. Eastern Cooperative Oncology Group (ECOG) 0 to 1
- •5. Agreement 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
- •1. Histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC, or pancreatic cancer
- •2. Subjects with HNSCC must have received a platinum-containing regimen and a PD-1 inhibitor if approved for the subject’s indication in the subject’s locality
- •3. Relapsed or refractory DLBCL after 2 lines of systemic therapy. At least 1 line should contain anti-CD20-based immunochemotherapy, and subjects should not be candidates for autologous hematopoietic stem cell transplantation
- •4. Subjects with pancreatic cancer should have rece
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 Day 1), unstable angina pectoris, uncontrolled congestive heart failure (New York Heart Association >Class II), 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 multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or clinically significant 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
- •- Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
- •- Severe renal impairment (creatinine clearance [CrCl] <30 mL/min)
- •3. Concurrent systemic treatment with an anticancer biologic within 30 days prior to receiving study drug or with a non-biological anticancer drug within 14 days prior to receiving 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 anemia with transfusion dependency of =3 months
- •11. Use of iron chelators
- •12. Major surgery within 3 months prior to study enrollment
- •13. Live vaccine within 28 days prior to planned dose
- •14. Participation in an ongoing clinical study involving medications, radiation, or surgery
- •15. Women who are pregnant or breast-feeding
研究者
相似试验
进行中（未招募）
1 期
A phase 1-2, first-in-human study of CX-2029 in adults with advanced solid tumors which cannot be removed completely through surgery, or cancer of B cells, a type of white blood cell responsible for producing antibodies.Metastatic or locally advanced unresectable solid tumor or diffuse large B-cell lymphomaMedDRA version: 20.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10061534Term: Oesophageal squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10041826Term: Squamous cell carcinoma of lungSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001456-34-GBCytomX Therapeutics, Inc.150
终止
1 期
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid TumorsSolid Tumor, AdultNon Small Cell Lung CancerHead and Neck CancerBreast CancerOvarian CancerNCT03149549CytomX Therapeutics99
进行中（未招募）
1 期
A Phase 1/2 Study of DCC-3116 in Patients With MAPK Pathway Mutant Solid TumorsMelanoma, Pancreatic Ductal Adenocarcinoma, Metastatic Solid Tumor, Advanced Solid Tumor, Colorectal Cancer, Non-Small Cell Lung CancerMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10053571Term: Melanoma Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10061451Term: Colorectal cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10051971Term: Pancreatic adenocarcinoma Class: 10029104CTIS2022-501474-19-00Deciphera Pharmaceuticals Inc.223
进行中（未招募）
1 期
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple MyelomaRelapsed or refractory Multiple Myeloma (r/r MM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003414-12-DEHeidelberg Pharma AG130
招募中
2 期
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma2024-515273-10-00Heidelberg Pharma AG71