Women of child-bearing potential (WOCBP) and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 3 months following the last study treatment Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011 Have a corrected QT interval (QTc) < 470ms for females and < 450ms for males (as calculated by the Fridericia correction formula) Subjects with lower ANC may be enrolled if not the result of prior therapy, if approved by medical monitor Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L (without the use of hematopoietic growth factors). Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless prior history of Gilbert's syndrome Serum creatinine 30 kg/m2 then lean body weight must be used Have the following laboratory values (obtained ≤ 28 days prior to first infusion day): Have a predicted life expectancy of ≥ 3 months Subjects with PS 2 may be considered for enrollment in Parts C and D, if approved by medical monitor Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. If the tumor site to be biopsied was previously irradiated or is the target lesion for response assessment, it must be at least 2 cm and have progressed All subjects in Parts C and D must have available and consent to provide archival tumor tissue, have a lesion that can be biopsied at acceptable clinical risk (as judged by the investigator), and agree to a fresh biopsy between screening and C1D1. All subjects in Parts A and B Expansion must have a tumor lesion that can be biopsied at acceptable risk and must agree to both a fresh biopsy between screening and Cycle 1 Day 1 (C1D1) and a second biopsy after completion of two cycles of study treatment All subjects in Parts A and B must have available and consent to provide archival tumor tissue Have histologically or cytologically confirmed cancer that is recurrent, metastatic, or persistent after at least one line of therapy and with no further standard treatment options evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, with at least one measurable lesion that has objectively progressed since (or on) previous treatment (unless subject has refused standard of care treatment), as assessed by enrolling physician and meet the requirements for the intended study cohort
#Stanford immunotherapy free clinical trials trial#
Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
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