Spots Global Cancer Trial Database for IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
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Trial Identification
Brief Title: IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
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
Study ID: NCT05958121
Study Description
Brief 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)
Detailed Description: 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)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Universitaetsklinikum Heidelberg AöR, Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Mannheim GmbH, Mannheim, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm AöR, Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Erlangen AöR, Erlangen, Bavaria, Germany
Klinikum Nürnberg, Nuremberg, Bavaria, Germany
Universitaetsklinikum Regensburg, Regensburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg AöR, Wuerzburg, Bavaria, Germany
Universitaetsklinikum Bonn AöR, Bonn, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf GmbH, Duesseldorf, 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
Universitaetsklinikum Magdeburg AöR, Magdeburg, Saxony-Anhalt, 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
Contact Details
Name: Immatics Biotechnologies GmbH
Affiliation: Immatics Biotechnologies GmbH
Role: STUDY_DIRECTOR
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