Studieninformationen
Kurztitel:
CatalYm CTL-002-001
Beschreibung:

A PHASE I, FIRST IN HUMAN, TWO PART, OPEN-LABEL CLINICAL TRIAL OF INTRAVENOUS ADMINISTRATION OF CTL-002 GIVEN AS MONOTHERAPY AND/OR IN COMBINATION WITH AN ANTI-PD-1 CHECKPOINT-INHIBITOR IN SUBJECTS WITH ADVANCED STAGE, RELAPSED/REFRACTORY SOLID TUMORS

Studiendesign:
Phase I/IB, , Multizentrisch, International
Therapielinien:
,
Alter:
>= 18 Jahre
Ein-/Ausschlusskriterien:
Main Inclusion Criteria: Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. Male or female aged ≥ 18 years. Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer Progressed on/relapsed after at least one prior anti-PD-1/PD-L1 treatment Biopsy-accessible tumor lesions and willing to undergo triple sequential tumor biopsy (Part A). At least 1 radiologically measurable lesion per RECIST V1.1/imRECIST (Part B). Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Life expectancy > 3 months as assessed by the Investigator. Adequate organ function (bone marrow, hepatic, renal function and coagulation). Main Exclusion Criteria: Pregnant or breastfeeding. Any tumor-directed therapy within 21 days before study treatment. Treatment with investigational agent within 21 days before study treatment. Radiotherapy within 14 days before study treatment. Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (NYHA II-IV), any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time < 6 months prior to Screening. Left ventricular ejection fraction (LVEF) < 50% measured by echocardiogram or MUGA. QTcF > 450 ms for men or > 470 ms for women. Any active autoimmune requiring systemic immunosuppressive treatments. . Any history of non-infectious pneumonitis < 6 months prior to Screening. Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present < 6 months prior to Screening. History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (< 6 months prior to Screening).
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
common:study_status_active
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie
Frau Dr. Maria-Elisabeth Goebeler
Goebeler_M@ukw.de
Herr Dr. med. Manik Chatterjee
Chatterjee_M@ukw.de