A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- Characterize the adverse events associated with CDX-1127 administration
研究概览
简要总结
This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.
详细描述
CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and also on certain hematologic tumor cells and may act to promote anti-tumor effects.
This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell and T-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system.
Eligible patients who enroll in the dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127. This first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies.
During the Expansion phase, cohorts of approximately 15 patients each will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer. Expansion cohorts may be limited to one or more tumor types.
Patients enrolled in the study may receive study treatment for up to 5 cycles, until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Among other criteria, patients must meet the following conditions to be eligible for the study:
- •18 years of age or older.
- •Body Weight ≤ 120 kg.
- •Histologic diagnosis of either a B-cell or T-cell hematologic malignancy known to express CD27 or one of the following solid tumors: metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer. For the solid tumor expansion cohorts, enrollment is limited to the following solid tumors: melanoma and renal cell carcinoma.
- •Tumor must be recurrent or treatment refractory with no remaining alternative, approved therapy options, with the following exception: melanoma patients enrolled in the expansion phase must have previously received ipilimumab and, for patients with the BRAF V600E mutation, vemurafenib, or have been offered such therapies and refused, and patients must have progressive disease subsequent to previous therapies.
- •Measurable or evaluable disease.
- •Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
- •If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
- •Have little or no side effects remaining from prior cancer therapies.
- •Provide written informed consent.
排除标准
- •Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- •Known prior primary or metastatic brain or meningeal tumors.
- •Receiving treatment with immunosuppressive agents, including any systemic steroids.
- •Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C.
- •Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter patency.
- •Women who are pregnant or lactating.
- •Prior allogeneic bone marrow transplant.
- •Autologous bone marrow transplant within 100 days of first dosing.
- •Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on treatment type).
- •Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks prior to first dosing.
研究组 & 干预措施
Solid Tumors (Expansion Phase; COMPLETED)
Several expansion cohorts of up to 15 patients each are planned, including melanoma and renal cell carcinoma.
干预措施: CDX-1127 (Drug)
Hematologic Malignancies (Dose Escalation)
B-Cell Enrollment COMPLETED T-Cell Enrollment COMPLETED
干预措施: CDX-1127 (Drug)
Solid tumors (Dose Escalation; COMPLETED)
干预措施: CDX-1127 (Drug)
Hematologic Malignancies (COMPLETED)
Several expansion cohorts of up to 15 patients each are planned, including Hodgkin lymphoma.
干预措施: CDX-1127 (Drug)
结局指标
主要结局
Characterize the adverse events associated with CDX-1127 administration
时间窗: Safety follow up is 70 days from last dose.
Analysis of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX-1127.
次要结局
- Levels of anti-CD27 antibodies in circulating blood.(Until end of treatment)
- Activity Evaluations(Until disease progression)
- Levels of CDX-1127 in circulating blood.(Until end of treatment)
- Immune system effects (eg: lymphoid cell populations and serum cytokine levels)(Until end of treatment)