NL-OMON52188尚未招募不适用
A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination with Durvalumab in Subjects with Advanced Solid Tumors. Sub-study title: CD8+ Imaging Sub-study Protocol - D8510C00001 / ICON # 0597/0115
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
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
- •Please note that due to removing inclusion/ exclusion criteria not relevant for
- •the protocol conducted in The Netherlands, the numbers deviate from those in
- •the Main Protocol.
- •Subjects must meet all of the following criteria:
- •1. Subjects >= 18 years of age.
- •2. Have given written informed consent prior to any study prior to performing
- •any protocol related procedures, including screening evaluations.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •4. Have at least 1 measurable lesion, other than the planned injected
- •lesion(s), using standard techniques by RECIST v1.1. Injected tumor lesion(s)
- •must be deemed clinically feasible for injection by the investigator.
- •a. A previously irradiated lesion, or a lesion subjected to other loco-regional
- •therapy, can be considered a target lesion only if the lesion has clearly
- •progressed during or after most recent therapy, and is well defined, measurable
- •per RECIST v1.1.
- •b. Subjects undergoing fresh tumor biopsies must have additional non-target
- •lesions that can be biopsied at acceptable risk as judged by the investigator
- •or if no other lesion is deemed suitable for biopsy, then a RECIST v1.1 target
- •lesion used for biopsy must be >= 2 cm in longest diameter.
- •5. Adequate bone marrow, renal, and hepatic function
- •a. Hematological (criteria listed cannot be met with recent blood transfusions
- •or require ongoing growth factor support within 2 weeks of starting study
- •treatment):
- •i. Absolute neutrophil count >= 1.5 × 109/L (1,500/mm3).
- •ii. Platelet count >= 100 × 109/L (100,000/mm3).
- •iii. Hemoglobin >= 9.0 g/dL within first 2 weeks prior to first dose.
- •b. Renal: calculated creatinine clearance (CrCL) (Cockcroft-Gault formula will
- •be used to calculate CrCL) or 24-hour urine CrCl > 50 mL/min.
- •c. Hepatic:
- •i. TBL <= 1.5 × ULN; for subjects with documented/suspected Gilbert's syndrome
- •or liver metastases, bilirubin <= 3 × ULN.
- •ii. AST and ALT <= 3 × ULN if no demonstrable liver metastasis; <= 5 x ULN in the
- •presence of liver metastases.
- •iii. Albumin > 3 g/dL.
- •iv. International normalized ratio (INR) and activated partial thromboplastin
- •time (aPTT) < 1.5 × ULN.
- •6. Prior to the first dose of MEDI1191, subjects with central nervous system
- •(CNS) metastases must have been treated and must be asymptomatic and meet the
- •a. No concurrent treatment, inclusive of but not limited to surgery, radiation,
- •and/or corticosteroids.
- •b. Subjects must be clinically stable with no CNS symptoms following CNS
- •treatment for a period of at least 28 days prior to first dose of MEDI1191.
- •c. At least 7 days since last dose of corticosteroids first dose of MEDI1191.
- •NOTE: Subjects with clinical symptoms or cord compression or with
- •leptomeningeal disease are excluded from the study.
- •7. Cessation of immunosuppressive medications including systemic
- •corticosteroids at doses exceeding 12 mg/day prednisone or equivalent,
- •methotrexate, azathioprine, ustekinumab (Stelara®), and tumor necrosis factor
- •(TNF) a/IL 6 blockers for at least 7 days prior to the first dose of MEDI1191
- •(corticosteroids at doses of 12 mg/day prednisone equivalent or lower, inhaled,
- 另有 3 项未显示
排除标准
- •Please note that due to removing inclusion/ exclusion criteria not relevant for
- •the protocol conducted in The Netherlands, the numbers deviate from those in
- •the Main Protocol.
- •Any of the following would exclude the subject from participation in the study:
- •1. Prior IL-12 either alone or as part of a treatment regimen.
- •2. Concurrent enrollment in another clinical study within 30 days prior to
- •treatment administration, unless it is an observational (non interventional)
- •clinical study or the follow-up period of an interventional study.
- •3. Receipt of live attenuated vaccines within 30 days prior to the first dose
- •of study treatment. Subjects who receive study treatment should not receive
- •live or live attenuated vaccine during the study and 30 days after the last
- •dose of investigational products.
- •4. Known allergy or hypersensitivity to any component of MEDI1191 or durvalumab
- •formulations.
- •5. Active or prior documented autoimmune disorders within the past 5 years
- •prior to the first scheduled dose of study treatment. The following are
- •exceptions to this criterion:
- •a. Subjects with vitiligo or alopecia.
- •b. Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on
- •hormone replacement.
- •c. Any chronic skin condition that does not require systemic therapy.
- •d. Subjects with celiac disease controlled by diet alone.
- •6. History of primary immunodeficiency, other immune-deficiency states (eg,
- •myelodysplastic disorders, marrow failure states, human immunodeficiency virus
- •infection [even if viral load is undetectable], history of solid organ
- •transplant, bone marrow allograft), or active tuberculosis (in settings where
- •there is clinical or radiographic evidence of tuberculosis, active disease must
- •be excluded prior to enrollment in line with local practice).
- •7. History of coagulopathy resulting in uncontrolled bleeding, eg, hemophilia,
- •von Willebrand's disease. History of other bleeding disorders or a Grade >= 3
- •bleeding event within 3 months prior to first dose of investigational products.
- •8. Require continuous anticoagulation or antiplatelet therapy (except for <= 100
- •mg acetylsalicylic acid [ASA]) which cannot be interrupted for more than 7 days
- •for IT delivery of MEDI1191.
- •9. Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or
- •hormonal therapy for cancer. NOTE: Concurrent use of hormones for
- •noncancer-related conditions (eg, insulin for diabetes and hormone replacement
- •therapy for post-menopausal symptoms) or specific cancer-related conditions
- •(ie, LHRH-based hormonal therapy for prostate cancer with documented
- •progression) is acceptable. Local treatment of isolated lesions for palliative
- •intent is acceptable (eg, by local surgery or radiotherapy)
- •10. Receipt of any conventional or investigational anticancer therapy within 21
- •days or palliative radiotherapy within 7 days prior to the first dose of study
- •treatment. For subjects who have received prior immunotherapy, the following
- •additional exclusion criteria apply:
- •a. Received only one dose of prior immunotherapy agent alone or as part of a
- •combination regimen within 21 days.
- •b. Experienced a toxicity that led to permanent discontinuation of prior
- •immunotherapy
- •c. All AEs while receiving prior immunotherapy did not resolve to <= Grade 1 or
- 另有 1 项未显示
研究者
相似试验
招募中
1 期
Phase I study of MGY825 in patients with advanced non-small cell lung canceradvanced non-small cell lung cancerJPRN-jRCT2031220278Yamauchi Kyosuke12
进行中（未招募）
1 期
PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid TumorsJPRN-jRCT2031210676Kawai Norisuke240
已完成
不适用
A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic MalignanciesBlood cancerLeukaemias10024324NL-OMON41336Epizyme, Inc.10
招募中
不适用
A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients with PSMA+ Advanced and/or Metastatic Solid Tumours (POTENTIA)NL-OMON52294Crescendo Biologics Limited20
招募中
1 期
A Phase I clinical trial evaluating the Safety, Tolerability, and Efficacy of Oral AUR107 in Patients with Advanced CancerCTRI/2023/05/052954Aurigene Oncology Limited