EUCTR2020-005923-35-PL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 193 人开始时间: 2021年1月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 193
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 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 Eastern Cooperative Oncology Group (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 National Cancer Institute Common
- •Terminology Criteria for Adverse Events [NCI CTCAE] v5.0, Appendix 2),
- •except for alopecia, lymphopenia assessed as non-clinically significant,
- •sensory neurotoxicity and erectile dysfunction that could be = Grade 2
- •7. At least a 4-week interval between the last received radiotherapy and
- •the first scheduled day of dosing with RVU120 (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
- •10. Laboratory values at Screening and /or at Day 1 Cycle 1 pre-dose:
- •a. Absolute neutrophil count =1.5 x 109/L without colony stimulating
- •factor support
- •b. Platelets > 100 x 109/L
- •c. Only for Part 1: Hemoglobin =9 g/dL (or =2.2 mmol/L) without red
- •blood cell transfusion within 4 weeks
- •d. Serum albumin = 30g/L (3.0g/dL)
- •e. Total bilirubin <1.5 times the upper limit of normal (ULN)
- •f. Aspartate aminotransferase (AST ; SGOT) =3 x ULN; alanine
- •aminotransferase (ALT ;SGPT) =3 x ULN; (=5 x ULN for patients with advanced solid tumors with liver metastases); Alkaline phosphatase = 5
- •x ULN for patients with advanced solid tumors with bone or liver
- •g. Creatinine clearance =60 mL/min (Cockcroft-Gault formula Appendix
- •h. Normal coagulation (elevated international normalized ratio [INR],
- •prothrombin time or activated partial thromboplastin time [APTT] <1.3 x
- •ULN acceptable)
- •11. Left ventricular ejection fraction> 50% by echocardiogram or
- •multiple gated acquisition (MUGA)
- •12. Able to provide an archival or fresh tumor biopsy sample at
- •Screening. For patients in Part 2, baseline tumor biopsy samples from
- •progressive disease lesions, where feasible, are required
- •13. For women of childbearing potential (WOCBP), a negative pregnancy
- •test must be confirmed before enrolment. WOCBP must commit to using
- •highly effective contraception during study participation and until 6
- •months after the last dose of study drug (see Appendix 5). Females must
- •also refrain from donating blood or egg (ovum) during the same timeperiod
- •14. For males, an effective barrier method of contraception must be used
- 另有 8 项未显示
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
- •3. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or
- •viral infection and acute inflammatory conditions (including pancreatitis)
- •4. Known HIV infection with a CD4+ T-cell (CD4+) count of < 350
- •cells/µL or a history of AIDS defining opportunistic infection within the
- •past 12 months or on established antiretroviral therapy for < 4 weeks or
- •presenting with a viral load of > 400 copies/mL prior to enrollment or on
- •antiretroviral therapy or prophylactic antimicrobials that are expected to
- •cause significant drug-drug interactions or overlapping toxicities with
- •study treatment and cannot be changed to alternative agents
- •5. Known positive test of / or known active diagnosis of COVID-19 viral
- •6. Ongoing significant liver disease such as cirrhosis, drug-induced liver
- •injury, active hepatitis or chronic persistent hepatitis B and/or C
- •Positive serologic or polymerase chain reaction (PCR) test results for
- •acute or chronic hepatitis B virus (HBV) infection. Patients whose HBV
- •infection status cannot be determined by serologic test results must be
- •negative for HBV by PCR to be eligible for study participation
- •(www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf)
- •Acute or chronic hepatitis C virus (HCV) infection. Patients who are
- •positive for HCV antibody must be negative for HCV by PCR to be eligible
- •for study participation
- •7. Impairment of gastrointestinal function or gastrointestinal disease
- •that may significantly alter the absorption of RVU120 (e.g., active
- •inflammatory bowel disease, ulcerative disease, malabsorption
- •syndrome, short bowel syndrome, uncontrolled nausea, persistent
- •vomiting or diarrhea)
- •8. Ongoing drug-induced pneumonitis
- •9. Concurrent participation in another investigational clinical trial
- •10. 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 SOC 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 6)
- •11. Mean measurement QTcF of >470 msec on triplicate
- •electrocardiograms (ECGs) performed within 5 minutes of each other,
- •using QTcF (Fredericia) formula
- •12. 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/index.php/login/dlcheck (Appendix 7)
- •(antibiotics, antifungals, and antivirals that are used as standard of care
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