NL-OMON48864已完成不适用
A Phase Ib, open label, multicenter study of the safety and efficacy of MIW815 (ADU-S100) administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas - MIW815 (ADU-S100) intratumoral injection with PDR001 (CMIW815X2102J)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male and female *18 years of age.
- •2. Measurable disease as determined by RECIST v1.1 (for solid tumors) or Cheson
- •2014 criteria (for lymphoma).
- •3. At least two sites of disease amenable to biopsy, and willing to undergo new
- •tumor biopsy at screening and during therapy. See protocol page 30-31 for
- •4. Dose escalation part: Advanced/metastatic solid tumors or lymphomas that
- •have progressed despite standard therapy or where standard therapy is not
- •tolerated, for whom no standard therapy exists or for whom standard therapy is
- •not reasonably effective.
- •5. Dose expansion part: Melanoma patients with accessible cutaneous or
- •subcutaneous lesions, who have relapsed or progressed after responding to a
- •PD-1 inhibitor or who are refractory to PD-1 Inhibitors, HNSCC or patients with
- •other accessible cutaneous or subcutaneous solid tumors and lymphomas, that
- •have progressed despite standard therapy or are intolerant of standard therapy,
- •for whom no standard therapy exists or for whom standard therapy is not
- •reasonably effective. In addition, patients with injectable visceral lesions
- •who have MSS CRC or other solid tumors with accessible visceral lesions, who
- •have progressed despite standard therapy or are intolerant of standard therapy,
- •for whom no standard therapy exists or for whom standard therapy is not
- •reasonably effective.
- •6. ECOG performance status 0-1
排除标准
- •1. Patients who require immediate local palliative measures such as XRT or
- •2. Symptomatic or untreated leptomeningeal disease.
- •3. Symptomatic -CNS metastases, see protocol page 31 for details.
- •4. Laboratory abnormalities:
- •- Creatinine > 1.5 x upper limit of normal (ULN)
- •- Total bilirubin > 1.5 x ULN (except for Gilbert*s syndrome > 3.0 x ULN)
- •- ALT and AST (liver) > 3 x ULN (except when livermetastasis > 5 x ULN_
- •- Absolute neutrophil count < 1.0 x 109/L
- •- Platelet count < 75 x 109/L, except for patients in Group C: platelet count <
- •100 x 109/L
- •- INR > 1.5 x ULN and/or aPTT > 1.5 x ULN, except for patients in Group C: INR
- •and aPTT must be normal
- •- Hemoglobin (Hgb) < 9 g/dL (5,59 mmol/l)
- •- Potassium, magnesium, calcium or phosphate > grade 1 using CTCAE v4.03
- •5. Impaired cardiac function or clinically significant cardiac disease, see
- •protocol page 42 for details.
- •6. Active, known or suspected autoimmune disease or a documented history of
- •autoimmune disease, see protocol page 43 for details.
- •7. Active infection requiring systemic antibiotic therapy.
- •8. Cytotoxic or targeted antineoplastics within 14 days prior to the first dose
- •of study treatment, see protocol page 43 for details.
- •9. Systemic chronic steroid therapy (* 10mg/day prednisone or equivalent) or
- •any immunosuppressive therapy 7 days prior to start of study treatment.
- •10. Use of any live vaccines against infectious diseases within 4 weeks of
- •initiation of study treatment.
- •11. Use of G-CSF and comparable, see protocol page 43/44 for details.
研究者
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