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

NCT05958121 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Immatics Biotechnologies GmbH

Phase

Phase 1/2

Started

2023-08-09

Last updated

2026-09-01

Condition(s) studied

Refractory CancerRecurrent CancerSolid Tumor, AdultCancer

Investigational drug(s) / intervention(s)

IMA402IMA402 and checkpoint inhibitorIMA402 and chemotherapyIMA402 and IMA401IMA402 and monoclonal antibodyIMA402 and chemotherapy +/- monoclonal antibody

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Phase I: Number of patients with dose limiting toxicities (DLTs) — 24 months
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) — 40 months
Phase I/II: Number of patients with serious TEAEs — 40 months
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations — 40 months
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations — 40 months
Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) — 40 months

Trial sites (29)

Facility	City	Region	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Baden-Wurttemberg	Recruiting
Thoraxklinik Heidelberg gGmbH	Heidelberg	Baden-Wurttemberg	Recruiting
Universitaetsklinikum Mannheim GmbH	Mannheim	Baden-Wurttemberg	Recruiting
Universitaetsklinikum Tuebingen AöR	Tübingen	Baden-Wurttemberg	Recruiting
Universitaetsklinikum Ulm AöR	Ulm	Baden-Wurttemberg	Recruiting
Universitaetsklinikum Erlangen AöR	Erlangen	Bavaria	Recruiting
Klinikum Nürnberg	Nuremberg	Bavaria	Completed
Universitaetsklinikum Regensburg	Regensburg	Bavaria	Recruiting
Universitaetsklinikum Wuerzburg AöR	Würzburg	Bavaria	Recruiting
Goethe University Frankfurt	Frankfurt am Main	Hesse	Recruiting
Justus-Liebig-Universitaet Giessen	Giessen	Hesse	Recruiting
Philipps-Universitaet Marburg	Marburg	Hesse	Recruiting
Sana Klinikum Offenbach GmbH	Offenbach	Hesse	Not Yet Recruiting
Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH	Buxtehude	Lower Saxony	Recruiting
Universitaetsmedizin Goettingen	Göttingen	Lower Saxony	Not Yet Recruiting
Universitaetsklinikum Bonn AöR	Bonn	North Rhine-Westphalia	Recruiting
Marien Hospital Duesseldorf GmbH	Düsseldorf	North Rhine-Westphalia	Recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH	Essen	North Rhine-Westphalia	Recruiting
Universitaetsklinikum Essen AöR	Essen	North Rhine-Westphalia	Recruiting
Johannes Wesling Klinikum Minden	Minden	North Rhine-Westphalia	Recruiting
Universitaet Muenster	Münster	North Rhine-Westphalia	Not Yet Recruiting
Klinikum Chemnitz gGmbH	Chemnitz	Saxony	Completed
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR	Dresden	Saxony	Recruiting
University Of Leipzig	Leipzig	Saxony	Recruiting
Universitaetsklinikum Magdeburg AöR	Magdeburg	Saxony-Anhalt	Recruiting
Antoni von Leeuwenhoek- Netherlands Cancer Institute	Amsterdam	North Holland	Recruiting
Leiden Universitair Medisch Centrum	Leiden	South Holland	Recruiting
Universitair Medisch Centrum Groningen	Groningen	Netherlands	Recruiting
Universitair Medisch Centrum Utrecht	Utrecht	Netherlands	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05958121 on ClinicalTrials.gov ↗ ← All trials in the Netherlands