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

Recruiting now · Phase 1/Phase 2

Conditions studied: Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer

In brief

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)

Key facts

Study ID

NCT05958121

Run by

Immatics Biotechnologies GmbH

People needed

400

Starts

2023-08-09

Expected to finish

2027-09-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥ 18 years old
• Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
• Patients must have received or not be eligible for indicated standard-of-care treatments per cohort
• Measurable disease according to RECIST 1.1
• Confirmed HLA status
• ECOG Performance Status of 0 to 1
• Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status

You may not qualify if…

• Other active malignancies that require treatment or that might interfere with the trial endpoints
• The patient is pregnant or is breastfeeding
• History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
• The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
• Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation

Where it is running

• Universitaetsklinikum Heidelberg AöR — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
• Universitaetsklinikum Magdeburg AöR — Magdeburg, Saxony-Anhalt, Germany (enrolling)
• Antoni von Leeuwenhoek- Netherlands Cancer Institute — Amsterdam, North Holland, Netherlands (enrolling)
• Leiden Universitair Medisch Centrum — Leiden, South Holland, Netherlands (enrolling)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands (enrolling)
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (enrolling)
• Universitaetsklinikum Mannheim GmbH — Mannheim, Baden-Wurttemberg, Germany (enrolling)
• Universitaetsklinikum Ulm AöR — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Universitaetsklinikum Erlangen AöR — Erlangen, Bavaria, Germany (enrolling)
• Klinikum Nürnberg — Nuremberg, Bavaria, Germany (enrolling)
• Universitaetsklinikum Regensburg — Regensburg, Bavaria, Germany (enrolling)
• Universitaetsklinikum Wuerzburg AöR — Würzburg, Bavaria, Germany (enrolling)
• Goethe University Frankfurt — Frankfurt am Main, Hesse, Germany (enrolling)
• Justus-Liebig-Universitaet Giessen — Giessen, Hesse, Germany (enrolling)
• Philipps-Universitaet Marburg — Marburg, Hesse, Germany (enrolling)
• Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH — Buxtehude, Lower Saxony, Germany (enrolling)
• Universitaetsklinikum Bonn AöR — Bonn, North Rhine-Westphalia, Germany (enrolling)
• Marien Hospital Duesseldorf GmbH — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
• KEM I Evang. Kliniken Essen-Mitte gGmbH — Essen, North Rhine-Westphalia, Germany (enrolling)
• Universitaetsklinikum Essen AöR — Essen, North Rhine-Westphalia, Germany (enrolling)
• Johannes Wesling Klinikum Minden — Minden, North Rhine-Westphalia, Germany (enrolling)
• Klinikum Chemnitz gGmbH — Chemnitz, Saxony, Germany (enrolling)
• Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR — Dresden, Saxony, Germany (enrolling)
• University Of Leipzig — Leipzig, Saxony, Germany (enrolling)
• Thoraxklinik Heidelberg gGmbH — Heidelberg, Baden-Wurttemberg, Germany

Full record on ClinicalTrials.gov

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