A Multicenter, Open-label, Dose-escalating, Phase I Trial with GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients with Progressive Disease after Standard Systemic Therapy in Cancers with Positive PSCA Marker
Phase I, , Monozentrisch, National
>= 18 Jahre
Inclusion Criteria: Male or female patients, ≥ 18 years of age PSCA positive cancer (i.e. urogenital tract (renal, transitional cell, prostate), non-small cell lung, breast and pancreatic cancer) refractory to standard treatments and with no other available standard or curative treatment Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Life expectancy of at least 2 months Platelets > 50,000/µl Hemoglobin > 9 g/dl Adequate renal and hepatic laboratory assessments Adequate pulmonary function with oxygen saturation (SpO2) > 89 % and no structural pulmonary disease which might jeopardize patient safety according to judgement of the investigator Left ventricular ejection fraction (LVEF) of ≥ 45 % Existing port-system or central venous catheter resp. acceptance of implantation of a device A female of childbearing potential may be enrolled providing she has a negative pregnancy test at screening visit and is routinely using a highly effective method of birth control resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization) until 3 months from the last study drug administration. Male patients must also practice a highly effective method of birth Control Able to give written informed consent Exclusion Criteria: Other malignancy requiring active therapy Non-measurable tumor disease Patients with brain metastases Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life); patients with experimental checkpoint inhibitors at all Other investigational drug within the past 4 weeks before start of trial medication Patients undergoing renal dialysis Pulmonary disease with clinical relevant hypoxia Evidence of active, non-infectious pneumonitis or history of interstitial lung disease Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease Renal outflow obstruction, macroscopic or significant microscopic hematuria Active infectious diseases considered by investigator to be incompatible with protocol Major surgery within 28 days Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants Pregnant or breastfeeding women Psychiatric disorders, drug and/or alcohol abuse Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) Known hypersensitivity to GEM3PSCA excipients Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance) Incapability of understanding purpose and possible consequences of the trial Patients who should not be included according to the opinion of the investigator
Studienaktive Standorte
Universitätsklinikum Würzburg
97080 Würzburg
Interdisziplinäres Studienzentrum mit Early Clinical Trial Unit
Herr Prof. Dr. Ralf C. Bargou
Herr Dr. med. Manik Chatterjee