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 doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia) * To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) Secondary objectives: * To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) * To describe the PK of IMA402 as monotherapy and in combination (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
400
IV infusions
IMA402 IV infusions and checkpoint inhibitor
IMA402 IV infusions and chemotherapy
IMA402 and IMA401 IV infusions
IMA402 IV infusions and monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody
Universitaetsklinikum Heidelberg AöR
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGThoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Tuebingen AöR
Tübingen, Baden-Wurttemberg, 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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Universitaetsklinikum Ulm AöR
Ulm, Baden-Wurttemberg, Germany
RECRUITINGUniversitaetsklinikum Erlangen AöR
Erlangen, Bavaria, Germany
RECRUITINGKlinikum Nürnberg
Nuremberg, Bavaria, Germany
COMPLETEDUniversitaetsklinikum Regensburg
Regensburg, Bavaria, Germany
RECRUITINGUniversitaetsklinikum Wuerzburg AöR
Würzburg, Bavaria, Germany
RECRUITINGGoethe University Frankfurt
Frankfurt am Main, Hesse, Germany
RECRUITING...and 19 more locations