EUCTR2021-005873-25-BE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
入排标准
- 性别
- All
入选标准
- •Inclusion criteria applicable to all trial parts
- •Age =18 years
- •Written informed consent given prior to any trial-specific procedures
- •Adequate organ function as assessed by the following parameters: hematologic; hepatic; renal; prothrombin time/international normalized ratio (INR); albumin; proteinuria.Serum concentrations of potassium, magnesium, and calcium within normal range
- •Eastern Cooperative Oncology Group (ECOG) performance status =1
- •Estimated life expectancy =3 months as per investigator’s assessment
- •A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
- •A 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 SOT-102 or first-line SoC treatment (whichever occurs later)
- •Male patients must agree to use a condom during treatment and for 9 months after SOT102 or first-line SoC treatment discontinuation. Male pat wishing to become a father during or after the trial should consider sperm preservation. WOCBP partner of male part should use highly effective contrac methods for 9 months after SOT102 or first-line SoC treat disc
- •Left ventricular ejection fraction (LVEF) =50% as determined by echocardiography or nuclear medicine methodology (multiple gated acquisition scanning [MUGA])
- •QTcF interval <450 msec on screening electrocardiogram (ECG)
- •Patient is, in the judgement of the investigator, an appropriate candidate for experimental therapy
- •Patient agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period)
- •All previous cancer therapies for locally advanced gastric/pancreatic cancer and any agents that have not received regulatory approval for any indication must have been discontinued prior to day 1 of cycle 1.
- •Adequate tumor tissue or cytology sample or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
- •Patient has advanced inoperable or metastatic disease
- •Patient has received and/or has been determined to be intolerant of all standard of care therapy known to confer clinical benefit
- •Measurable or non-measurable disease according to RECIST 1.1
- •Histological or cytological evidence of adenocarcinoma of the stomach or GEJ or pancreas that is advanced or metastatic
- •Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
- •Patient has advanced inoperable or metastatic disease
- •Patient must have at least one measurable lesion according to RECIST 1.1
- •Patients with gastric/GEJ adenocarcinoma (gastric B)
- •Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
- •Must have HER2-negative tumors
- •Patients with pancreatic adenocarcinoma (pancreatic B)
- •Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
- •Adequate 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.
- •Patient has advanced inoperable or metastati
排除标准
- •Prior therapy with any agent directed at CLDN18.2
- •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
- •Patient has been previously treated with the maximum cumulative dose of anthracyclines
- •Severe preexisting medical conditions as per judgement of the investigator
- •History of interstitial pneumonitis or pulmonary fibrosis
- •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.
- •Patient has peripheral sensory neuropathy grade =2
- •Active infection requiring systemic therapy that is not clinically controlled before the signature of the ICF
- •Patients with HIV will be eligible if
- •CD4+ T-cell (CD4+) counts =350 cells/uL
- •they have no history of AIDS-defining opportunistic infections
- •they are not currently on HIV therapy
- •Patients with hepatitis B will be eligible if:
- •there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and anti-HBc–positive
- •Patients with hepatitis C will be eligible if:
- •they have completed curative antiviral treatment and have HCV viral load below the limit of quantification
- •Alcohol or drug abuse as determined by the investigator
- •Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the patient is able to comply with trial requirements
- •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
- •History of major ventricular arrhythmias
- •History or family history of congenital long QT syndrome
- •Bradycardia (<50 beats per minute)
- •Family history of sudden cardiac death before age 50
- •Major surgical intervention =28 days prior to ICF signature or incomplete wound healing after surgical intervention
- •Hypersensitivity or intolerance to any component of trial intervention
- •Vaccination with a live or live-attenuated vaccine within 30 days prior the first dose of trial interventions
- •Part A Part C
- •Any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
- •General. Patients must not have received any systemic therapy for metastatic desease. Patients must not have received any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
- •Patients with contraindications to any component of the first-line SoC treatment
- •Patients with clinically active inflammatory bowel disease
- •Patients with gastric/GEJ adenocarcinoma (gastric B):
- •Dihydropyrimidine dehydrogenase (DPD) deficiency
- •Patient has been treated with immunosuppressive medications =14 days prior to day 1 of cycle 1.
- •Concomitant use of drugs known to prolong the QT/QTc interval
- •Patients with pancreatic adenocarcinoma (pancreatic B)
- •Patients more clinically suitable (e.g., with BRCA1/2 mutation) to receive treatment with leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) as compared to nab-paclitaxel and gemcitabine according to the investigator’s opinion
- •Patients must not have received any systemic therapy for metastatic disease.Patients must not have received any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
研究者
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