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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05359445
Other study ID # IMA401-101
Secondary ID 2023-506854-19-0
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 19, 2022
Est. completion date November 2027

Study information

Verified date February 2024
Source Immatics Biotechnologies GmbH
Contact Immatics Biotechnologies GmbH
Phone Please E-Mail
Email Ctgovinquiries@immatics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary objective: - To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 Secondary objectives: - To characterize the safety and tolerability of IMA401 - To evaluate initial anti-tumor activity of IMA401 - To describe the pharmacokinetics of IMA401


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2027
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 solid tumor - Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®) - Life expectancy > 2 months - ECOG Performance Status of 0 to 2 - 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 Exclusion Criteria: - 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 or rescue medications, if no alternative treatment option is available - 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 any clinically relevant, active infection - Systemic corticosteroids (= 10 mg/day prednisone or equivalent) received 2 weeks prior to starting IMA401 therapy - Patients with active brain metastases

Study Design


Intervention

Biological:
IMA401 (Phase Ia)
Intravenous infusions in escalating dose levels
IMA401 (Phase Ib)
Treatment at recommended dose for extension (RDE)

Locations

Country Name City State
Germany Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie Berlin
Germany Universitätsklinikum Bonn AöR, Medizinische Klinik IIII Bonn North Rhine-Westphalia
Germany Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III Chemnitz Saxony
Germany Universitaetsklinikum C. - G. - Carus Dresden, Technische Universitaet Dresden AöR, NCT/UCC Early Clinical Trial Unit Dresden Saxony
Germany Marien Hospital Duesseldorf GmbH, Klinik fuer Onkologie/Haematologie und Palliativmedizin Duesseldorf North Rhine-Westphalia
Germany Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU Erlangen Bavaria
Germany Universitaetsklinikum Essen AöR, Innere Klinik (Tumorforschung) Westdeutsches Tumorzentrum Essen Essen North Rhine-Westphalia
Germany Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I Freiburg Baden-Wurttemberg
Germany Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation Hanover Lower Saxony
Germany Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten Heidelberg Baden-Wurttemberg
Germany Universitaetsklinikum Schleswig- Holstein, Campus Kiel, Medizinische Klinik II Haematologie und Onkologie, Karl-Lennert Tumorzentrum Kiel Schleswig- Holstein
Germany Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL) Leipzig Saxony
Germany Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, III. Medizinische Klinik Mainz Rhineland-Palatinate
Germany Universitaetsklinikum Muenster AöR, Medizinische Klinik A Muenster North Rhine-Westphalia
Germany Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III Munich Bavaria
Germany Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie Nuremberg Bavaria
Germany Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3 Regensburg Bavaria
Germany Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen Tuebingen Baden-Wurttemberg
Germany Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU Ulm Baden-Wurttemberg
Germany Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU Wuerzburg Bavaria

Sponsors (2)

Lead Sponsor Collaborator
Immatics Biotechnologies GmbH Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with dose limiting toxicities 44 months
Secondary Number of patients with treatment-emergent adverse events (TEAEs) 68 months
Secondary Number of patients with serious TEAEs 68 months
Secondary Number of patients with treatment emergent adverse events of special interest (AESIs) 68 months
Secondary Frequency of dose interruptions and reductions 68 months
Secondary Duration of dose interruptions and reductions 68 months
Secondary Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using RECIST v1.1 and iRECIST 68 months
Secondary Disease control rate (DCR) of CR, PR or stable disease (SD) lasting 6 or more weeks following the initiation of IMA401 68 months
Secondary Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST 68 months
Secondary Progression-free survival (PFS) based on RECIST v1.1 and iRECIST 68 months
Secondary Overall survival (OS) 68 months
Secondary Determination of PK parameter: maximal serum concentration (Cmax) 44 months
Secondary Determination of PK parameter: time at Cmax (Tmax) 44 months
Secondary Determination of PK parameter: minimal serum concentration (Cmin) 44 months
Secondary Determination of PK parameter: area under the serum concentration-time curve (AUC) 44 months
Secondary Determination of PK parameter: clearance (Cl) 44 months
Secondary Determination of PK parameter: volume of distribution (Vss) 44 months
Secondary Determination of PK parameter: half-life (t1/2) 44 months
Secondary Determination of PK parameter: assessment of dose-proportionality 44 months
Secondary Determination of PK parameter: steady-state attainment 44 months
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