The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors. Primary objectives: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I) * To characterize the safety and tolerability of IMA402 (Phase I/II) * To evaluate anti-tumor activity of IMA402 (Phase II) Secondary objectives: * To evaluate the initial anti-tumor activity of IMA402 (Phase I) * To evaluate anti-tumor activity of IMA402 (Phase II) * To describe the PK of IMA402 (Phase I/II)
The study will be conducted in two phases: * Phase Ia: Dose escalation/de-escalation * Phase Ib: Dose extension * Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Intravenous infusions in escalating dose levels
Treatment at MTD and/or RDE (Phase Ib)
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
Universitaetsklinikum Heidelberg AöR
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Ulm AöR
Ulm, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Erlangen AöR
Erlangen, Bavaria, Germany
Phase I: Number of patients with dose limiting toxicities (DLTs)
Time frame: 24 months
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Time frame: 40 months
Phase I/II: Number of patients with serious TEAEs
Time frame: 40 months
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Time frame: 40 months
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
Time frame: 40 months
Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Time frame: 40 months
Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
Time frame: 37 months
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
Time frame: 40 months
Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST
Time frame: 40 months
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Time frame: 40 months
Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Time frame: 40 months
Phase I/II: Overall survival (OS)
Time frame: 40 months
Phase I/II: Determination of PK parameter: half-life (t1/2)
Time frame: 40 months
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)
Time frame: 40 months
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)
Time frame: 40 months
Phase I/II: Determination of PK parameter: area under the curve (AUC)
Time frame: 40 months
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Klinikum Nürnberg
Nuremberg, Bavaria, Germany
RECRUITINGUniversitaetsklinikum Regensburg
Regensburg, Bavaria, Germany
RECRUITINGUniversitaetsklinikum Wuerzburg AöR
Würzburg, Bavaria, Germany
RECRUITINGJustus-Liebig-Universitaet Giessen
Giessen, Hesse, Germany
RECRUITINGPhilipps-Universitaet Marburg
Marburg, Hesse, Germany
RECRUITINGElbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
Buxtehude, Lower Saxony, Germany
RECRUITING...and 14 more locations