ACTRN12616000787482已完成1 期
MILGa-01: A first in human study to evaluate the safety and tolerability of monoclonal antibody conjugate MILGa (MIL-38/Gallium67) in patients with advanced prostate, bladder and pancreatic cancer.
Minomic International0 个研究点目标入组 12 人开始时间: 2016年6月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •*Written informed consent provided.
- •*18 years old or older.
- •*Histologically or cytologically confirmed diagnosis of
- •a. Prostate cancer
- •b.Urothelial cancer (bladder, ureter, urethra, renal pelvis)
- •c.Pancreatic cancer
- •*Metastatic disease as assessed by CT, bone, or MRI within 14 days of MILGa scan.
- •a. At least two metastases and up to 15 metastases
- •b.Stable or slowly progressing disease as determined by the Investigator
- •c.For prostate cancer the minimal standard scans is CT Chest/Abdomen/Pelvis (CAP) and whole body bone scan.
- •d.For urothelial and pancreas cancer the minimal standard scans is CT CAP.
- •* No change of anti-cancer therapy within 4 weeks of study entry and none planned for at least 2 weeks after study entry.
- •*Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. Subjects with performance status of 2 may be enrolled in at the discretion of the Investigator.
- •*Male subjects must agree to use contraception methods. This criterion must be followed from the time of the dose of study medication until 4 weeks after.
- •*A female subject is eligible to participate if she is of:
- •a.Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and oestradiol < 40 pg/mL (<140 pmol/L) is confirmatory].
- •b.Child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until four weeks after the last dose of study medication.
- •*Adequate organ system function
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1.Patients with extensive bone marrow involvement as defined by abnormal haematological values or prostate cancer patients with super scan” on standard imaging (nuclear bone scan)
- •2.Change in anti-cancer therapy planned for 4 weeks before or two weeks after MILGa scan.
- •3.Currently receiving cytotoxic chemotherapy that is expected to cause grade 3 neutropenia or grade 3 thrombocytopenia.
- •4.Patients with rapidly progressing metastatic disease as determined by the Principal Investigator
- •5.Any major surgery, radiotherapy or immunotherapy in the four weeks preceding MILGa dosing
- •6.Concurrent condition precluding the patient from following study protocol.
- •7.QTc interval of greater than 450 msec
- •8.Unwillingness or inability to follow study procedures.
- •9.Known immediate or delayed hypersensitivity reactions to study drug.
研究者
相似试验
招募中
不适用
Phase I First Time in Human Open Label Study of GSK3745417 administered with and without Anticancer Agents in Participants with Advanced Solid Tumors (study 208850)solide tumorensolid tumorsNL-OMON56334GlaxoSmithKline25
已完成
1 期
Can taking a plant extract improve blood glucose in adult men with pre-diabetes? First in human studyPre-DiabetesMetabolic and Endocrine - DiabetesAlternative and Complementary Medicine - Herbal remediesDiabetesACTRN12617001605381niversity of Otago16
进行中（未招募）
1 期
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple MyelomaRelapsed or refractory Multiple Myeloma (r/r MM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003414-12-DEHeidelberg Pharma AG130
招募中
2 期
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma2024-515273-10-00Heidelberg Pharma AG71
尚未招募
1 期
A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy SubjectsInflammatory and Immune System - Autoimmune diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonPrimary Biliary CholangitisACTRN12624000967583Parvus Therapeutics, Inc.36