EUCTR2020-004163-12-ES进行中（未招募）1 期
An Open-Label Phase Ib/II Study of Surufatinib in Combination with Tislelizumab in Subjects With Advanced Solid Tumors
Hutchison MediPharma Limited0 个研究点目标入组 107 人开始时间: 2021年7月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
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
- •1. Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines
- •2. =18 years of age
- •3. Part 1: have evaluable lesions (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1])
- •Part 2: have measurable lesions (according to RECIST v1.1)
- •4. Absolute neutrophil count (ANC) of =1.5×109/L, platelet count of =100×109/L, and hemoglobin =9 g/dL
- •5. Serum total bilirubin (TBIL) <1.5 times the upper limit of normal (ULN)
- •6. Proteinuria <2+ by urinalysis; if proteinuria =2+, proteinuria <1 g by 24-hour urinary protein test is required
- •7. Patients without liver metastases: must have alanine aminotransferase (ALT) and/or AST levels =2.5 times the ULN. Patients with liver metastases: must have ALT and AST levels =5 times the ULN
- •8. Creatinine clearance =45 mL/min
- •9. International normalized ratio (INR) =1.5 × ULN and activated partial thromboplastin time (aPTT) =1.5 × ULN, unless the patient is currently receiving anticoagulants for prophylactic purposes.
- •10. Have a performance status of 0 or 1 on the ECOG scale
- •11. Female patients of childbearing potential and male patients with partners of childbearing potential: agree to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly.
- •Dose Escalation:
- •12. Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type that has progressed on or are intolerant of standard therapies and for which no curative therapy exists.
- •Dose Expansion:
- •13. Histologically or cytologically documented, locally advanced or metastatic.
- •a. Cohort A: adenocarcinoma of the colon or rectum that is microsatellite stable. Patients must have progressed on, or had discontinued due to intolerable toxicity to, at least 3 prior regimens of standard therapy. Treatment progression is defined as disease progression during or within 3 months after the last dose of standard therapy. Prior therapy could have included adjuvant chemotherapy if a tumor had recurred within 6 months after the last administration of treatment. Patients must have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and, if RAS wild-type, an anti-epidermal growth factor receptor antibody therapy
- •a. Cohort B: progressive, low, or intermediate grade (Grade 1 or Grade 2) NETs of thoracic (B1) or GEP (B2) origins. Patients must have radiological documentation of progression of disease in the last 6 months prior to the initiation of study treatment and must have progressed on at least 1 line of standard therapy for metastatic disease.
- •i. For NETs originating from the thorax,
- •A. Grade 1 is defined as <2 mitoses/10 high-power field (HPF) and no necrosis.
- •B. Grade 2 is defined as 2-10/10 HPF and/or foci of necrosis.
- •ii. For NETs originating from GEP,
- •A. Grade 1 is defined as <2 mitoses/10 HPF and/or <3% Ki-67 index.
- •B. Grade 2 is defined as 2-20/10 HPF and/or 3-20% Ki-67 index
- •iii. If the mitotic ratio and Ki-67 index correspond to different grade, the higher grade is used to assign classification.
- •iv. Patients who have functioning NETs and have been on a stable dose of an SSA for a minimum of 2 months prior to the first dose of study treatment for control of their secretory symptoms will be eligible.
- •b. Cohort C: SCLC that has progressed on standard first line
排除标准
- •1. AEs due to previous antitumor therapy has not recovered to CTCAE =Grade 1, except alopecia and peripheral neurotoxicity with CTCAE =Grade 2
- •2. Part 2 patients with CRC (Cohort A), NETs (Cohort B), and STS (Cohort E): previous treatment with anti-PD-1, anti-PD-L1/L2 antibodies, anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody, or any other antibody acting on T cell costimulatory or checkpoint pathway
- •Note: Patients in the Part 1 and patients in Part 2 Cohorts C and D (SCLC and GC) may have received previous treatment with anti-PD-1, anti-PD-L1/L2 antibodies, CTLA-4 antibody, or any other antibody acting on T cell costimulatory or checkpoint pathway;
- •3. Previous treatment with surufatinib
- •4. Uncontrollable hypertension, defined as systolic blood pressure (BP) =140 mmHg and/or diastolic BP =90 mmHg
- •5. Gastrointestinal disease or condition that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumor with active bleeding, or other gastrointestinal
- •conditions that may cause bleeding or perforation by investigator's discretion
- •6. History or presence of a serious hemorrhage (>30 mL within 3 months), hemoptysis (>5 mL blood within 4 weeks), or life-threatening thromboembolic event within 6 months
- •7. Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris or coronary artery bypass grafting, congestive heart failure according to the New York Heart Association classification =2, ventricular arrhythmias which need drug treatment, or left ventricular ejection fraction (LVEF) <50%
- •8. QT interval corrected by the method of Fredericia (QTcF) =480 milliseconds
- •9. Other malignant tumors within 5 years prior to screening (except cured basal-cell carcinoma or squamous carcinoma at skin and cervical carcinoma in situ)
- •10. Antitumor therapy received within 2 weeks or 5 half-lives, whichever is shorter, prior to the initiation of the investigational treatment, including, but not limited to, chemotherapy, radical radiotherapy, targeted therapy, immunotherapy, hepatic embolization, cryoablation, and radiofrequency ablation
- •11. Palliative radiotherapy for a bone metastasis lesion within 2 weeks prior to the initiation of the study treatment
- •12. Strong inducers or inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A) taken within two weeks prior to the first study treatment
- •13. Any clinically significant active infection, including, but not limited to, known human immunodeficiency virus (HIV) infection
- •14. Known history of active viral hepatitis. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with hepatitis c virus (HCV) infection who are currently on treatment
- •are eligible if they have an undetectable HCV viral load. Patients with an unknown history of viral hepatitis must be screened for HBV with HBs antigen; HBc antibody and HBS antibody; and HBV-DNA, if indicated and for HCV with HCV antibody.
- •a. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for >2 weeks before the first dose of study treatment.
- •b. Patients with a negative HCV antibody test at Screening or po
研究者
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