EUCTR2019-003998-26-ES进行中（未招募）1 期
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1044 in subjects with malignant solid tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 378
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. Subject with locally advanced or metastatic solid tumor(s) (excluding subjects with primary central nervous system [CNS] tumors), who has experienced disease progression while on standard therapy or is intolerant of, or not eligible for, standard therapy.
- •2. Must be =18 years of age.
- •3. Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the trial and is willing to participate in the trial prior to any trial related assessments or procedures.
- •4. Must have measurable disease according to response assessment criteria relevant to the tumor type
- •5. Must have an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1 at Screening and on C1D1.
- •6. Must have acceptable laboratory parameters
- •7. A woman of reproductive potential must agree to use adequate contraception during the trial and for 4 months after the last GEN1044 administration. Adequate contraception is defined as highly effective methods of contraception.
- •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 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 148
排除标准
- •1. Has an uncontrolled intercurrent illness, including but not limited to:
- •a. Ongoing or active infection requiring intravenous treatment with anti-infective therapy
- •b. Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia.
- •c. Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg, despite optimal medical management.
- •d. Ongoing or recent evidence of significant autoimmune disease
- •e. Subjects with a history of grade 3 or higher irAEs that led to treatment discontinuation
- •f. Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
- •g. History of chronic liver disease or evidence of hepatic cirrhosis.
- •h. History of non-infectious pneumonitis that has required steroids, or currently has pneumonitis.
- •i. History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1044.
- •j. Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
- •2. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new or symptomatic brain metastases or stroke.
- •3. Prior therapy:
- •a. Radiotherapy: Radiotherapy within 14 days prior to first GEN1044 administration. Palliative radiotherapy will be allowed.
- •4. Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1044 administration. Toxicities from previous anti-cancer therapies that have not resolved
研究者
相似试验
进行中（未招募）
1 期
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumorsMalignant solid tumors: Patients with advanced and/or metastatic colorectal cancer (CRC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), gastric (incl. esophagogastric junction) cancer, pancreatic cancer or urothelial cancer.MedDRA version: 20.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864EUCTR2017-001394-16-ESGenmab B.V.206
进行中（未招募）
1 期
A Safety study of GEN1047 in patients with malignant solid tumorsMalignant Solid Tumors, per protocol GCT1047-01MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864EUCTR2021-001790-23-ESGenmab A/S380
招募中
1 期
GEN1047 for Solid Tumors - First in Human (FIH) TrialMalignant Solid TumorsMedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104CTIS2024-510722-10-00Genmab A/S333
进行中（未招募）
1 期
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumorsMalignant solid tumors:Patients with advanced and/or metastatic colorectal cancer (CRC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), gastric (incl. esophagogastric junction) cancer, pancreatic cancer or urothelial cancer.MedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864EUCTR2017-001394-16-GBGenmab B.V.48
进行中（未招募）
1 期
GEN1046 Safety Trial in Patients With Malignant Solid TumorsMalignant solid tumors:Patients with relapsed or refractory, advanced and/or metastatic non-small cell lung cancer (NSCLC), endometrial carcinoma (EC), urothelial carcinoma (UC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), or cervical cancer who are not anymore candidates for or refuse standard therapyMedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864EUCTR2018-003402-63-CZGenmab A/S380