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临床试验/EUCTR2020-003109-73-DE
EUCTR2020-003109-73-DE进行中（未招募）1 期

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with KRT-232 in Subjects with Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)

Telios Pharma, Inc.0 个研究点目标入组 70 人开始时间: 2020年12月4日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
70
研究概览入排标准研究者记录与标识符相似试验

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

  • •Subjects in the Phase 1b and Phase 2 Dose Expansion must meet all the following criteria in order to be eligible for the study:
  • •1.Adults =18 years of age who are able to provide informed consent.
  • •2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • •3.Documented primary TP53wt AML or TP53wt AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization (WHO) criteria (Arber 2016).
  • •4.Subject is refractory to and/or relapsed after at least one prior therapy with no alternative therapeutic options likely to produce clinical benefit. Subjects must have received a FLT3 inhibitor (unless contraindicated), if FLT3 inhibitors are approved and available in the country in which the subject is to be treated.
  • •5.Presence of the FLT3 activating mutation TKD or FLT3-ITD in bone marrow or peripheral blood detected by a test approved by the local health authority or, if not available, by a validated test.
  • •6.Adequate renal function within 7 days (Phase 1b) or 28 days (Phase 2) prior to the first dose of study treatment defined as an estimated creatinine clearance =30 mL/min by Cockcroft-Gault formula.
  • •7.Adequate hepatic function within 7 days (Phase 1b) or 28 days (Phase 2) prior to the first dose of study treatment defined as:
  • •a.Total serum bilirubin = 2.0 x ULN. Subjects with known Gilbert’s syndrome or disease-related hemolysis must have a total bilirubin =3.0 X ULN
  • •b.Serum AST and/or ALT =2.5×ULN.
  • •8.Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use a highly effective contraception method during the study. In addition, after the last dose of study drug, female subjects must continue to use a highly effective method of contraception for 1 month and 1 week and male subjects must continue to use a highly effective method of contraception for 3 months and 1 week. A woman is considered of childbearing potential (ie, fertile, following menarche and until becoming post menopausal) unless permanently sterile.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 35
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 35

排除标准

  • •Subjects in the Phase 1b and Phase 2 Dose Expansion who meet any of the following criteria will not be eligible for the study:
  • •1.Acute promyelocytic leukemia (AML subtype M3).
  • •2.Subjects with known active central nervous system involvement with AML.
  • •3.Prior treatment with MDM2 antagonist therapies.
  • •4.Prior treatment with a BTK inhibitor.
  • •5.Chemotherapy, cytoreductive therapy, immune therapy, cytokine therapy or any investigational therapy within 14 days prior to first dose of study treatment. Subjects on FLT3 inhibitor therapy must discontinue treatment at least 2 days prior to first dose of study drug.
  • •6.Active participation in other therapeutic clinical trials including supportive care trials.
  • •7.Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment.
  • •8.Subjects who are eligible for an allogeneic hematopoietic stem cell transplantation (HSCT) per the opinion of the investigator and have a donor. Subjects who are HSCT eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study.
  • •9.Subjects with a history of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks prior to the first dose of study treatment
  • •10.Known infection with human immunodeficiency virus.
  • •11.Known active hepatitis B or C infection.
  • •12.History of another malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated non-metastatic prostate cancer with normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection or superficial transitional cell bladder carcinoma.
  • •13.Uncontrolled intercurrent illness including but not limited to clinically significant cardiac disease (New York Heart Class III or IV); symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or subjects with psychiatric illness/social situations that would limit compliance with study requirements; or subjects who have been committed to an institution by judicial or administrative authority.
  • •14.Grade 2 or higher QTc prolongation >480 msec per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
  • •15.History of myocardial infarction within 3 months of first dose of study treatment
  • •16.History of major organ transplant
  • •17.Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of the first dose of study drug.
  • •18.Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole); subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study provided the proton pump inhibitor is discontinued at least 3 days prior to first dose of study drug.
  • •19.Phase 1b only: Subjects receiving medications, herbal supplements, or food known to be strong inhibitors of CYP3A within 7 days prior to the first dose of TL-895
  • •20.Having history of difficulty swallowing, gastric or small bowel surgery with history of malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the KRT-232 or TL-895 treatment.
  • •21.Major surgery or planned major surgery within 28 days prior to first dose of stu

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