RecruitingPhase 1Phase 2NCT05958121

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

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


Sponsor

Immatics Biotechnologies GmbH

Enrollment

400 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called IMA402 (Phase II), a biological treatment called IMA402 (Phase Ia), and others for people with cancer, recurrent cancer, and other related conditions. The study is currently recruiting participants at 24 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIMA402

IV infusions

DRUGIMA402 and checkpoint inhibitor

IMA402 IV infusions and checkpoint inhibitor

DRUGIMA402 and chemotherapy

IMA402 IV infusions and chemotherapy

DRUGIMA402 and IMA401

IMA402 and IMA401 IV infusions

DRUGIMA402 and monoclonal antibody

IMA402 IV infusions and monoclonal antibody

DRUGIMA402 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

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NCT05958121


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