A phase I, multicenter, open-label dose escalation and expansion study of LOP628, administered intravenously in adult patients with cKit-positive tumors and acute myeloid leukemia - Phase I study with LOP628 in cKIT positive solid tumors and AM

ovartis0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Main inclusion criteria (all patients)
•*Documented cKit-positive neoplasms or AML
•*ECOG Performance status of * 2;Inclusion criteria for patients with solid tumors
•*Progressive disease as defined as either of the following:
•o Patients with SCLC: have progressed after at least 1 prior therapy
•o Patients with GIST: have relapsed or has refractory disease, and no further approved effective therapeutic option exists
•o Patients with other cKit-positive solid tumors (dose escalation only): have progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
•*Measurable disease as per RECIST v1.1 criteria ;Inclusion criteria for patients with AML
•*Progressive disease defined as relapsed or refractory non-PML AML following standard therapy or for whom no effective therapy exists.
•*Blast count < 50,000/mm3.;For all inclusion criteria refer to protocol section 5.2.2 page 23-24

•Main Exclusion criteria for all patients
•*Presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
•*History of serious allergic reactions, which may pose an increased risk of serious infusion reactions.
•*Previously treated with cKit directed therapies ;Exclusion criteria for patients with solid tumors
•*Central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment. ;Exclusion criteria for patients with AML
•*Prior allogeneic bone marrow transplant (BMT).;For all exclusion criteria refer to protocol section 5.2.3 page 2-25

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