NL-OMON54504招募中不适用
A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects with Advanced Solid Tumours. - MATINS
Faron Pharmaceuticals Ltd0 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
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 99（—）
入选标准
- •1) Written Informed Consent
- •2) Aged >= 18 years male or female
- •3) Tumour sample should be collected during screening period. If a recent
- •tumour biopsy obtained within six months before the date of consent is
- •available (or older, as agreed on a case by case basis with the sponsor), that
- •may be used. At the discretion of the sponsor, the tumour sample may be
- •optional for certain subjects in Part III
- •4) Life expectancy > 12 weeks
- •5) Histologically confirmed advanced (inoperable or metastatic) malignancies in
- •which (according to the view of the investigator) no curative, effective or
- •suitable treatment options exist:
- •o Hepatocellular carcinoma
- •o Gallbladder cancer or intra- or extrahepatic cholangiocarcinoma
- •o Colorectal adenocarcinoma
- •o Serous poorly differentiated (Grade 3) ovarian adenocarcinoma or
- •undifferentiated ovarian cancer
- •o Pancreatic ductal adenocarcinoma
- •o Immunotherapy (IO) resistant cutaneous melanoma (progression during
- •programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1)
- •or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody therapy)
- •o Uveal melanoma in Parts II and III
- •o Gastric adenocarcinoma (including adenocarcinoma of the distal esophagus / GE
- •junction) in Parts II and III
- •o ER+ breast cancer in Parts II and III
- •o Anaplastic thyroid cancer in Parts II and III
- •6) ECOG performance status 0 or 1
- •7) Measurable disease in Parts II and III
- •8) Adequate bone marrow, liver and kidney function defined as
- •Blood white blood cell >= lower limit of normal
- •Blood neutrophil count >= 1x109/L Blood platelet count >= 100x109/L, for HCC >=
- •Blood haemoglobin >= 9.0 g/dL
- •Creatinine clearance > 40 mL/min calculated by Cockcroft-Gault
- •formula AST <= 3 X ULN (<= 5 x ULN when HCC or hepatic metastases are
- •ALT <= 3 X ULN (<= 5 x ULN when HCC or hepatic metastases present)
- •Bilirubin <= 1.5 X ULN
- •Albumin >= 3.0 g/dL
- •The most recent measurements taken during the screening period must be within
- •the required limits for the patient to be considered eligible (i.e. criteria
- •met once during the screening period are not sufficient if there are more
- •recent measurements available that are not within the required
- •limits. It is however acceptable to repeat measurements if the initial
- •measurements or subsequent measurements taken during the screening period are
- •not within the required limits; the patient is eligible providing that the
- •newest measurements are within the required limits). However,
- •once a subject is out of the screening period, and has had eligibility
- •confirmed and been enrolled, the pre-dose laboratory assessments are not
- •subjected to inclusion criteria limits, but only for investigators assessment
- •of subject safety.
- •9) Women of child-bearing potential must have a negative pregnancy test in
- •serum prior to trial entry
- 另有 3 项未显示
排除标准
- •1) Less than 21 days since the last dose of intravenous anticancer chemotherapy
- •or less than five half-lives from a small molecule targeted therapy or oral
- •anticancer chemotherapy before the first IMP administration
- •2) Any immunotherapy within preceding 6 weeks from the first IMP administration
- •3) Investigational therapy or major surgery within 4 weeks before the first IMP
- •administration
- •4) Active clinically serious infection > Grade 2 NCI-CTCAE version 5.0 within
- •preceding 2 weeks before first IMP administration
- •5) Brain metastases
- •6) Subject has not recovered from the previous therapies to Grade <= 1 severity
- •as classified by the NCI-CTCAE version 5.0 (except Grade <= 2 alopecia,
- •neuropathy or thyroid disorders)
- •7) Pregnant or lactating women
- •8) History of second malignancy except for non-melanotic skin cancer, cervical
- •carcinoma in situ or superficial bladder cancer, or any other malignancy
- •treated previously with curative intent and more than three years without
- •9) Evidence of severe or uncontrolled systemic diseases, congestive cardiac
- •failure New York Heart Association class >= 2, Myocardial Infarction within 6
- •months or laboratory finding that in the view of the investigator makes it
- •undesirable for the subject to participate in the trial
- •10) Any medical condition that the Investigator considers significant to
- •compromise the safety of the subject or that impairs the interpretation of IMP
- •toxicity assessment
- •11) Confirmed human immunodeficiency virus infection
- •12) Symptomatic cytomegalovirus infection
- •13) Subjects with active auto-immune disorder (except type I diabetes, celiac
- •disease, hypothyroidism requiring only hormone replacement, vitiligo,
- •psoriasis, or alopecia)
- •14) The subject requires systemic corticosteroid or other immunosuppressive
- •15) Subjects with organ transplants
- •16) Subjects in dialysis
- •17) Use of Live (attenuated) vaccines for 30 days prior to the start of study
- •treatment, during treatment, and until last visit
- •18) Subject is unwilling or unable to comply with treatment and trial
- •instructions
- •19) Subjects with known hypersensitivity to the IMP or any of the
- •pharmaceutical ingredients
研究者
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