EUCTR2018-003402-63-CZ进行中（未招募）1 期
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors
适应症
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
- 380
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
- •For Dose Escalation:
- •Measurable disease according to RECIST 1.1.
- •Eastern Cooperative Oncology Group (ECOG) 0-1.
- •Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- •Subjects must have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
- •For Dose Expansion:
- •Measurable disease according to RECIST 1.1.
- •Eastern Cooperative Oncology Group (ECOG) 0-1.
- •Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- •Subjects must have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for or refuse standard therapy.
- •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 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 95
排除标准
- •Subject has uncontrolled intercurrent illness, including but not limited to:
- •Ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered less than 2 weeks prior to first dose
- •Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia.
- •Uncontrolled hypertension defined as systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg, despite optimal medical management.
- •Ongoing or recent (within 1 year) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
- •Subjects with a history of grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment should be excluded. Subjects with irAEs below grade 3 that led to discontinuation should be discussed with the sponsor.
- •Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade are excluded.
- •History of chronic liver disease or evidence of hepatic cirrhosis.
- •History of non-infectious pneumonitis that has required steroids or currently has pneumonitis.
- •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 GEN1046.
- •Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
- •Any history of intracerebral arteriovenous malformation, cerebral aneurysm or progressive brain metastases or stroke.
- •Prior therapy:
- •Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed.
- •Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab.
- •Subjects who discontinued treatment due to disease progression within the first 6 weeks of a CPI containing treatment.
- •Prior treatment with a 4-1BB (CD137) targeted agent.
- •Prior treatment with a T-cell agonist or anti-CTLA-4 targeted agent within 12 weeks prior to the initiation of treatment.
- •Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to grade 1 or less with the exception of alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to = grade 2.
研究者
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