A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignancies - CMAK683X2101 fase I/II study in advanced malignancies

ovartis0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- ECOG performance status 0 to 2
•- Patients progressed after standard therapy or are intolerant of standard therapy or for whom no standard therapy exists
•- Measurable disease according to RECIST v1.1 for patients with solid tumors or Cheson criteria for patients with DLBCL
•- Patients must have a site of disease amenable for biopsy. On-Treatment biopsy (C1D15) is required for patients with solid tumors
•- Histologically or cytologically confirmed diagnosis required for all indications
•- Patients with DLBCL: documentation of EZH2 mutational status required in phase II
•- Patients with NPC: documentation of presence of p16/CDKN2A gene required
•- Patients with ovarian cancer must have a primary tumor wiith great than 50% clear cell histomorphology
•- Patients with prostate cancer must have evidence of castration resistance: a confirmed rising PSA and a castrate-serum testosterone level (i.e. * 50 mg/dL);
•- Patients with sarcoma: Enrollment is limited to epithelioid sarcoma, other types of sarcoma with SWI/SNF alterations may be considered with approval from Novartis.;Other protocol inclusion criteria may apply (section 5.2)

•- Other malignant disease than the one being treated in this study
•- Severe and/or uncontrolled medical conditions that in the investigator*s opinion could affect the safety of individual or impair the assessment of study result.
•- B-cell lymphoma patients who have received prior allogeneic stem cell transplant
•- Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment (protocol section 5.3 bullet 10)
•- CNS involvement which are neurologically unstable or requiring increasing doses of steroids to control.
•- Insufficient bone marrow function at screening: Platelets * 50 x 109/L (50,000/mm3) - Hemoglobin (Hgb) * 90 g/L (9 g/dL) - Absolute neutrophil count (ANC) * 1.0 x 109/L (1000/mm3)
•- Insufficient hepatic and renal function at screening: ALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases) - Total bilirubin *2 x ULN - Serum creatinine > 1.5 x ULN and/or creatinine clearance * 50 mL/min
•- Unable to stop any prohibited medications, including strong CYP3A4 inhibitors or inducers, CYP3A4 or CYP2C8 substrates with a narrow therapeutic index, long acting proton pump inhibitors.;Other protocol-defined exclusion criteria may apply (protocol section 5.3)

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