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RECRUITING
NCT05958121
PHASE1/PHASE2

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

Sponsor: Immatics Biotechnologies GmbH

View on ClinicalTrials.gov

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 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)

Official title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

145

Start Date

2023-08-09

Completion Date

2027-09

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

IMA402 (Phase Ia)

Intravenous infusions in escalating dose levels

BIOLOGICAL

IMA402 (Phase Ib)

Treatment at MTD and/or RDE (Phase Ib)

BIOLOGICAL

IMA402 (Phase II)

Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)

Locations (24)

Universitaetsklinikum Heidelberg AöR

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Mannheim GmbH

Mannheim, 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

Justus-Liebig-Universitaet Giessen

Giessen, Hesse, Germany

Philipps-Universitaet Marburg

Marburg, Hesse, Germany

Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH

Buxtehude, 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