EUCTR2020-005923-35-ES进行中（未招募）1 期
An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients with Relapsed / Refractory Metastatic or Advanced Solid Tumors - RVU120 Phase I/II Solid Tumor Study
Ryvu Therapeutics S.A.0 个研究点目标入组 120 人开始时间: 2021年8月25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
- 120
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
- •General Inclusion Criteria for Part 1 and Part 2:
- •1.Age 18 years or older;
- •2.Histologically confirmed and/or documented advanced or metastatic tumors who have exhausted the available standard treatment(s) of the respective country and/or progressing from at least one previous systemic therapy and not eligible to further available therapy;
- •3.At least one measurable or evaluable disease according to RECIST v1.1 Appendix 1);
- •4.Performance status of ECOG 0-2 (Appendix 3);
- •5.Estimated life expectancy of at least 12 weeks;
- •6.Toxicities incurred as a result of previous anti-cancer therapy resolved to = Grade 1 (as defined by NCI CTCAE v5.0, Appendix 2), except for alopecia, lymphopenia assessed as non-clinically significant, sensory neurotoxicity and erectile dysfunction that could be = G2;
- •7.At least a 4-week interval between the last received radiotherapy and the first scheduled day of dosing with RVU120 (SEL120) (with the exception of palliation radiotherapy which is allowed up to 2 weeks prior the first scheduled day of dosing);
- •8.Complete recovery from major surgery (stable and < Grade 2 toxicity sequela acceptable);
- •9.At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted);
- •10.Laboratory values at Screening and or at D1C1 pre-dose:
- •a.Absolute neutrophil count =1.5 x 109/L without colony stimulating factor support;
- •b.Platelets 100 x 109/L;
- •c.Hemoglobin =9 g/dL (or =2.2 mmol/L) without RBC transfusion within
- •d.Serum albumin = 30g/L (3.0g/dL);
- •e.Total bilirubin <1.5 times the upper limit of normal (ULN);
- •f.AST (SGOT) =3 x ULN; ALT (SGPT) =3 x ULN; (=5 x ULN for patients with advanced solid tumors with liver metastases); patients with confirmed bone metastases will be permitted on study with isolated elevations in ALP >5 x ULN;
- •g.Creatinine clearance =60 mL/min (Cockroft-Gault formula Appendix 4);
- •h.Normal coagulation (elevated INR, prothrombin time or APTT <1.3 x ULN acceptable);
- •i.Urine protein =1+(as measured by dipstick) or urinary protein <1 g24/hrs.
- •11.Left ventricular ejection fraction> 50% by echocardiogram or MUGA;
- •12.Able to provide an archival or fresh tumor biopsy sample at Screening. For patients in Part 2 of study, baseline tumor biopsy samples from progressive disease lesions, where feasible, are required;
- •13.For females of childbearing potential (FCBP), a negative pregnancy test must be confirmed before enrolment. FCBP must commit to using two medically accepted forms of effective contraception during study participation and until 6 months after the last dose of study drug. Females must also refrain from donating blood or egg (ovum) during the same time-period;
- •14.For males, an effective barrier method of contraception must be used during study participation until 6 months after the last dose of study drug, if the patient is sexually active with a FCBP. Males must also refrain from donating blood or sperm during the same time-period;
- •15.Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice;
- •16.Capable of understanding the mandated and optional protocol requirements, is willing and able to comply with the study protocol procedures and has signed the main informed document prior to any study specific procedure. For any optional biopsy sampling (tissue and/or blood
排除标准
- •General Exclusion Criteria for both Part 1 and Part 2:
- •Any of the following will exclude a patient from enrolment:
- •1.Active brain metastasis [patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial];
- •2.Prior history of or planned organ or hematopoietic stem cell transplant;
- •3.Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis);
- •4.Known seropositivity or history of active viral infection with human immunodeficiency virus (HIV);
- •5.Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis or chronic persistent hepatitis B and/or C;
- •6.Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RVU120 (SEL120) (e.g., active inflammatory bowel disease, ulcerative disease, malabsorption syndrome, short bowel syndrome, uncontrolled nausea, persistent vomiting or diarrhea);
- •7.Ongoing drug-induced pneumonitis;
- •8.Concurrent participation in another investigational clinical trial;
- •9.Taking any medications, herbal supplements or other substances (including smoking) that are known to be strong inhibitors or strong inducers or sensitive substrates of CYP1A2; with the exception of antibiotics, antifungals, and antivirals that are used as the standard of care or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient and no suitable or available alternative could be found, with prior approval of the Sponsor Study Medical Director (Appendix 5);
- •10.Mean QTcF or QTcB of >470 msec on triplicate electrocardiograms (ECGs) performed within 5 minutes of each other, using QTcF (Fredericia) or QTcB (Bazett) formulation;
- •11.Currently taking drugs that are documented in the drug package insert, to have risk of causing prolonged QTc or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued). Please also consult the following Credible Meds web page: https://crediblemeds.org/pdftemp/pdf/CombinedList.pdf. Appendix 6. (antibiotics, antifungals, and antivirals that are used as standard of care or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient and no suitable or available alternative could be found, can be used with prior approval by Sponsor Study Medical Director);
- •12.Patients with clinically significant cardiovascular disease. This includes: Myocardial infarction or unstable angina < 6 months prior to Screening; NYHA Grade III or greater congestive heart failure (Appendix 7); cerebrovascular accident including transient ischemic attack within the past 6 months; Uncontrolled hypertension; Serious or uncontrolled cardiac arrhythmia; Personal history of Torsade de Pointe or syndrome of congenital QTc prolongation or QTc > 470 msec.;
- •13.Any other prior or current medical condition, intercurrent illness, surgical history, physical or electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the Investigator’s opinion, could jeopardize patient safety or interfere with the objectives of the study;
- •14.Pregnant or breast-feeding females;
- •15.Known active ongoing infection with COVID19 virus or known persistent Positive COVID
研究者
相似试验
进行中（未招募）
1 期
RVU 120 (SEL120) to be tested in for treatment patients with solid tumors who have failed previous available standard therapyRelapsed / Refractory Metastatic or Advanced Solid TumorsMedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864EUCTR2020-005923-35-PLRyvu Therapeutics S.A.193
招募中
1 期
RVU 120 (SEL120) to be tested in for treatment patients with solid tumors who have failed previous available standard therapyRelapsed / Refractory Metastatic or Advanced Solid TumorsMedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104CTIS2024-515131-30-00Ryvu Therapeutics S.A.54
进行中（未招募）
不适用
Sym004 in head and neck cancer patients failing anti-EGFR based therapyRecurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 14.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000902-24-DESymphogen A/S25
进行中（未招募）
1 期
Sym004 in head and neck cancer patients failing anti-EGFR based therapyRecurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)EUCTR2011-000902-24-BESymphogen A/S25
进行中（未招募）
1 期
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHon-Curable Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2009-013317-10-BEGenmab A/S26