EUCTR2021-005873-25-ES进行中（未招募）1 期
A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 269
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria applicable to all trial parts
- •1Age =18 years
- •2Written informed consent given prior to any trial-specific procedures
- •3Adequate organ function as assessed by the following parameters: hematologic; hepatic; renal; prothrombin time/international normalized ratio (INR); albumin; proteinuria.
- •4Eastern Cooperative Oncology Group (ECOG) performance status =1
- •5Estimated life expectancy =3 months as per investigator’s assessment
- •6A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
- •6.1Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
- •6.2A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 9 months after the last dose of SOT102
- •7Male patients must agree to use a condom during treatment and for 9 months after SOT102 or first-line SoC treatment discontinuation
- •8Left ventricular ejection fraction (LVEF) =50% as determined by echocardiography or nuclear medicine methodology (multiple gated acquisition scanning [MUGA])
- •9QTcF interval <450 msec on screening electrocardiogram (ECG)
- •10Patient is, in the judgement of the investigator, an appropriate candidate for experimental therapy
- •11Patient agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period)
- •12Adequate tumor tissue or cytology sample or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
- •13All previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued
- •14Patient has advanced inoperable or metastatic disease
- •15Patient has no better treatment option available
- •16Measurable or non-measurable disease according to RECIST 1.1
- •17Histological or cytological evidence of adenocarcinoma of the stomach or GEJ or pancreas that is advanced or metastatic
- •12Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
- •13Patient has advanced inoperable or metastatic disease
- •14Patient must have at least one measurable lesion according to RECIST 1.1
- •Patients with gastric/GEJ adenocarcinoma (gastric B)
- •15Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
- •16Must have HER2-negative tumors
- •Patients with pancreatic adenocarcinoma (pancreatic B)
- •15Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
- •12Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method.
- •13All previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued
- •14Patient has advanced inoperable or metastatic disease
- •15Measurable disease according to RECIST 1.1.
- •Patients with gastric/GEJ adenocarcinoma (gastric C)
- •16Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
- •17Must have received at least two prior systemic therapies for advanced or metastatic disease.
- •Patients with
排除标准
- •1.Prior therapy with any agent directed at CLDN18.2
- •2.Patient has received radiation therapy =14 days before day 1 of cycle 1 or has not recovered to grade =1 from treatment-related side effects
- •3.Severe preexisting medical conditions as per judgement of the investigator
- •4.History of interstitial pneumonitis or pulmonary fibrosis
- •5.Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days.
- •6.Patient has peripheral sensory neuropathy grade =2
- •7.Active infection requiring systemic therapy within =7 days prior to day 1 of cycle 1
- •8.Known history of HIV infection or known active hepatitis B or hepatitis C
- •9.Alcohol or drug abuse as determined by the investigator
- •10.Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the patient is able to comply with trial requirements
- •11.New York Heart Association class =3 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1
- •12.History of major ventricular arrhythmias
- •13.History or family history of congenital long QT syndrome
- •14.Major surgical intervention =28 days prior to ICF signature or incomplete wound healing after surgical intervention
- •15.Hypersensitivity or intolerance to any component of trial intervention
- •Part A Part B Part C and part D:
- •16.Any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
- •17.Any prior systemic therapy for metastatic cancer other than gastric
- •or pancreatic cancer.
- •Patients with gastric/GEJ adenocarcinoma (gastric B) only:
- •18.Dihydropyrimidine dehydrogenase (DPD) deficiency
- •19.Patient has been treated with immunosuppressive medications =14 days prior to day 1 of cycle 1.
- •17.Patients with contraindications to any component of the first-line SoC treatment
- •Patients with gastric/GEJ adenocarcinoma (gastric D) only:
- •18.DPD deficiency
- •19.Patient has been treated with immunosuppressive medications =14 days prior to day 1 of cycle 1
研究者
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