The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives: * To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab * To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab * To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Intravenous infusions in escalating dose levels
Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab
Treatment at recommended dose for extension (RDE)
Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I
Freiburg im Breisgau, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGThoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Number of patients with dose limiting toxicities
Time frame: 44 months
Number of patients with treatment-emergent adverse events (TEAEs)
Time frame: 93 months
Number of patients with serious TEAEs
Time frame: 93 months
Number of patients with treatment emergent adverse events of special interest (AESIs)
Time frame: 93 months
Frequency of dose interruptions and reductions
Time frame: 93 months
Duration of dose interruptions and reductions
Time frame: 93 months
Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using RECIST v1.1 and iRECIST
Time frame: 93 months
Disease control rate (DCR) of CR, PR or stable disease (SD) lasting 6 or more weeks following the initiation of IMA401
Time frame: 93 months
Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Time frame: 93 months
Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Time frame: 93 months
Overall survival (OS)
Time frame: 93 months
Determination of IMA 401 PK parameter: maximal serum concentration (Cmax)
Time frame: 44 months
Determination of IMA 401 PK parameter: time at Cmax (Tmax)
Time frame: 44 months
Determination of IMA 401 PK parameter: minimal serum concentration (Cmin)
Time frame: 44 months
Determination of IMA 401 PK parameter: area under the serum concentration-time curve (AUC)
Time frame: 44 months
Determination of IMA 401 PK parameter: clearance (Cl)
Time frame: 44 months
Determination of IMA 401 PK parameter: volume of distribution (Vss)
Time frame: 44 months
Determination of IMA 401 PK parameter: half-life (t1/2)
Time frame: 44 months
Determination of IMA 401 PK parameter: assessment of dose-proportionality
Time frame: 44 months
Determination of IMA 401 PK parameter: steady-state attainment
Time frame: 44 months
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Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU
Ulm, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU
Erlangen, Bavaria, Germany
RECRUITINGKlinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III
Munich, Bavaria, Germany
RECRUITINGKlinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie
Nuremberg, Bavaria, Germany
RECRUITINGUniversitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3
Regensburg, Bavaria, Germany
RECRUITINGUniversitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU
Würzburg, Bavaria, Germany
RECRUITING...and 13 more locations