IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

NCT05359445 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: IMA401-1012023-506854-19-00
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 21

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective:

• To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives:
• To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab
• To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab
• To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab

Conditions

Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult; Cancer

Keywords

MAGE-A4

Outcome Measures

Primary Outcomes (1)

• Number of patients with dose limiting toxicities

  44 months

Secondary Outcomes (19)

• Number of patients with treatment-emergent adverse events (TEAEs)

  93 months

• Number of patients with serious TEAEs

  93 months

• Number of patients with treatment emergent adverse events of special interest (AESIs)

  93 months

• Frequency of dose interruptions and reductions

  93 months

• Duration of dose interruptions and reductions

  93 months

Study Arms (3)

Dose-Finding IMA401 TCER® Monotherapy (Phase Ia)

EXPERIMENTAL

Dose-Finding Escalation/De-escalation with IMA401 TCER® (Phase Ia)

Biological: IMA401 (Phase Ia)

Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia)

EXPERIMENTAL

Dose-Finding Escalation/De-escalation of combination therapy with IMA401 TCER and pembrolizumab (Phase Ia)

Biological: IMA401 (Phase Ia); Biological: Pembrolizumab (Phase Ia)

Extension IMA401 TCER® Monotherapy (Phase Ib)

EXPERIMENTAL

IMA401 monotherapy extension cohort following the determination of the recommended dose for extension (RDE) (Phase Ib)

Biological: IMA 401 (Phase Ib)

Interventions

IMA401 (Phase Ia) BIOLOGICAL

Intravenous infusions in escalating dose levels

Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia); Dose-Finding IMA401 TCER® Monotherapy (Phase Ia)

Pembrolizumab (Phase Ia) BIOLOGICAL

Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab

Also known as: Keytruda®

Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia)

IMA 401 (Phase Ib) BIOLOGICAL

Treatment at recommended dose for extension (RDE)

Extension IMA401 TCER® Monotherapy (Phase Ib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures
• Patients ≥ 18 years old
• Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered
• Confirmed HLA status and IMA401 tumor target MAGE-A4 and/or MAGE-A8 expression
• Life expectancy \> 2 months
• ECOG Performance Status of 0 to 1
• Measurable disease according to RECIST 1.1
• Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status
• Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments
• The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy

You may not qualify if:

• Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
• History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab
• Patients with prior allogeneic stem cell transplantation or organ transplantation
• Patients with autoimmune diseases needing disease-directed treatment
• Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results
• Positive for HIV or with active hepatitis B or C infection.
• Patients with active infection
• Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment
• Patients with active central nervous system metastases and leptomeningeal metastases

Sponsors & Collaborators

• Immatics Biotechnologies GmbH: lead

Study Sites (21)

Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU

Erlangen, Bavaria, 91054, Germany

Location

Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III

Munich, Bavaria, 81675, Germany

Location

Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie

Nuremberg, Bavaria, 90419, Germany

Location

Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3

Regensburg, Bavaria, 93053, Germany

Location

Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU

Würzburg, Bavaria, 97078, Germany

Location

Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik II

Frankfurt am Main, Hesse, 60590, Germany

Location

Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Bonn AöR, Medizinische Klinik IIII

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Marien Hospital Duesseldorf GmbH, Klinik fuer Onkologie/Haematologie und Palliativmedizin

Düsseldorf, North Rhine-Westphalia, 40479, Germany

Location

Universitaetsklinikum Muenster AöR, Medizinische Klinik A

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, III. Medizinische Klinik

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III

Chemnitz, Saxony, 09116, Germany

Location

Universitaetsklinikum C. - G. - Carus Dresden, Technische Universitaet Dresden AöR, NCT/UCC Early Clinical Trial Unit

Dresden, Saxony, 01307, Germany

Location

Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinikum Schleswig- Holstein, Campus Kiel, Medizinische Klinik II Haematologie und Onkologie, Karl-Lennert Tumorzentrum

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie

Berlin, 12203, Germany

Location

Related Links

• Corporate Website

MeSH Terms

Conditions

Neoplasms; Recurrence

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Immatics Biotechnologies GmbH

  Immatics Biotechnologies GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 3, 2022
• Study Start: May 19, 2022
• Primary Completion: March 18, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (21)