EUCTR2021-005774-25-ES进行中（未招募）1 期
A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •1.Be 18 years of age on the day of signing informed consent
- •2.Ability to understand and sign written informed consent to participate in the study
- •3.Provides written informed consent for the study
- •4.Patients with the following histologically or cytologically confirmed solid tumor indications and line of treatment:
- •Colorectal cancer
- •Advanced hepatocellular carcinoma
- •Ovarian cancer
- •5.Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •mCRPC: Patients with both measurable and non-measurable disease will be enrolled. At least 35 patients with measurable disease will be enrolled. Patients with no measurable disease and only widespread bone disease must have a CTC count of >5 cells per 7.5 mL of blood.
- •6.Accessible tumor tissue available for fresh biopsy except for mCRPC with no accessible tumor tissue
- •7.Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1
- •8.Must have recovered from all AEs (except alopecia) due to previous therapies to grade =1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
- •Have adequate organ function as defined below. Specimens must be collected within 10 days prior to the start of study interventions.
- •9.Hematology:
- •9.1.Absolute neutrophil count =1500/µL
- •9.2.Platelets =100 000/µL
- •9.3.Hemoglobin =9.0 g/dL (criteria must be met without packed red blood cell transfusion within the prior 2 weeks; patients can be on a stable dose of erythropoietin [= 3 months])
- •10.Renal function: Creatinine clearance as measured by glomerular filtration rate =30 mL/min using Cockcroft-Gault equation
- •11.Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) =2.5× upper limit of normal (ULN) and total bilirubin =1.5×ULN or direct bilirubin = ULN in patients without liver metastasis (benign hereditary hyperbilirubinemias). In patients with liver metastasis, ALT/AST =5×ULN is allowed but total bilirubin must be =2×ULN.
- •12.Prothrombin time and activated partial thromboplastin time =1.5×ULN
- •13.Patients who are hepatitis B (HBV) surface antigen positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load before study entry (ICF signature).
- •14.Patients with history of hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening. Patients must have completed anti-viral therapy at least 4 weeks before study entry (ICF signature).
- •15.A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
- •15.1.Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for
- •12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.
- •15.2.A WOCBP who agrees to use a highly effective contraceptive method
排除标准
- •1.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade =3 AE
- •2.Prior exposure to drugs that are agonists of IL-2 or IL-15
- •3.Prior systemic anti-cancer therapies, including investigational agents, before study entry (ICF signature):
- •3.1.Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter)
- •3.2.Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
- •4.Has received prior radiotherapy within 2 weeks of the start of study interventions. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system disease.
- •5.NSCLC indication only: Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study interventions
- •6.Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study interventions
- •Prior/concurrent clinical study experience
- •7.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or 5 half lives (whichever shorter) before study entry (ICF signature). Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks or 5 half lives (whichever shorter) after the last dose of the previous investigational agent.
- •8.Clinically significant cardiac abnormalities including prior history of any of the following:
- •8.1.Cardiomyopathy, with left ventricular ejection fraction =50% at screening
- •8.2.Congestive heart failure of New York Heart Association grade =2
- •8.3.History of clinically significant, atherosclerotic cardiovascular disease, specifically myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study interventions, and any history of coronary heart disease and clinically significant peripheral and/or carotid artery disease
- •8.4.Prolongation of QTcF >450 msec
- •8.5.Clinically significant cardiac arrythmia that cannot be controlled with adequate medication
- •9.Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg. Patients with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry (ICF signature).
- •10.Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
- •11.Has had an allogeneic tissue/solid organ transplant
- •12.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study interventions
- •13.History of or serology positive for HIV
- •14.Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Patients with basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- •15.Has known active central nervous system metastases and/or carcin
研究者
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