A Phase 1, Multicenter, Open-Label, Dose-Escalation/Consolidation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Orally Administered JBI-778 in EGFR Mutated Lung Cancer Patients with or without Brain Metastasis, Isocitrate Dehydrogenase (IDH) Mutated WHO Grade 3/4 Recurrent Glioma and Adenoid Cystic Carcinoma (ACC) - Nil

Jubilant Therapeutics India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•Males or females aged = 18 years at the time of informed consent.
•Screening laboratory values:
•Absolute neutrophil count (ANC) =1,500 cells/mm3.
•Platelet count =100,000 cells/mm3.
•Total bilirubin =1.5× ULN (upper limit of normal). Patients with Gilbert’s
•syndrome may be enrolled with up to 3.0×ULN.
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×
•ULN (unless liver metastases are present then up to =5×ULN is allowed).
•Creatinine clearance (CrCL) = 40 mL/min based on the Cockcroft-Gault
•glomerular filtration rate estimation or other equally relevant calculations. (Refer
•in Appendix VIII)
•Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) =1.5×
•ULN if the patient is not on anticoagulants (If the patient is on anticoagulants, the
•patient must be on a stable dose for at least 2-weeks prior to screening).

•Treatment with systemic anticancer therapy or an investigational agent within 2-weeks or
•5 half-lives, whichever is shorter, prior to the start of study drug treatment.
•Major surgery = 21 days prior to starting study drug or has not recovered from adverse
•effects of such procedure.
•Surgery (e.g., stomach bypass) or medical condition that might significantly affect the
•absorption of medicines (as judged by the investigator).
•Radiotherapy within 4 week for brain metastases and 2-weeks for the rest of body part
•prior to the start of study drug treatment. Patients must have recovered from all
•radiotherapy-related toxicities prior to the start of study treatment.
•Severe or unstable medical condition, such as congestive heart failure (New York Heart
•Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension,
•uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac
•arrhythmia requiring medication (= Grade 2, according to NCI CTCAE V5), myocardial
•infarction within 6 months prior to starting study treatment, or any other significant or
•unstable concurrent cardiac illness. Note: stable chronic atrial fibrillation is allowed.

发起方

Jubilant Therapeutics India Limited