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IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Sponsor: Immatics Biotechnologies GmbH
Summary
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)
Official title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-08-09
Completion Date
2027-09
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
IMA402
IV infusions
IMA402 and checkpoint inhibitor
IMA402 IV infusions and checkpoint inhibitor
IMA402 and chemotherapy
IMA402 IV infusions and chemotherapy
IMA402 and IMA401
IMA402 and IMA401 IV infusions
IMA402 and monoclonal antibody
IMA402 IV infusions and monoclonal antibody
IMA402 and chemotherapy +/- monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody
Locations (29)
Universitaetsklinikum Heidelberg AöR
Heidelberg, Baden-Wurttemberg, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen AöR
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm AöR
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen AöR
Erlangen, Bavaria, Germany
Klinikum Nürnberg
Nuremberg, Bavaria, Germany
Universitaetsklinikum Regensburg
Regensburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg AöR
Würzburg, Bavaria, Germany
Goethe University Frankfurt
Frankfurt am Main, Hesse, Germany
Justus-Liebig-Universitaet Giessen
Giessen, Hesse, Germany
Philipps-Universitaet Marburg
Marburg, Hesse, Germany
Sana Klinikum Offenbach GmbH
Offenbach, Hesse, Germany
Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
Buxtehude, Lower Saxony, Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, Germany
Universitaetsklinikum Bonn AöR
Bonn, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf GmbH
Düsseldorf, North Rhine-Westphalia, Germany
KEM I Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen AöR
Essen, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Universitaet Muenster
Münster, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Saxony, Germany
University Of Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Magdeburg AöR
Magdeburg, Saxony-Anhalt, Germany
Antoni von Leeuwenhoek- Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Leiden Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands