Cancer Clinical Trial
Official title:
A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), in Patients With Recurrent and/or Refractory Solid Tumors.
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
| 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 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 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 active infection - Systemic corticosteroids (= 10 mg/day prednisone or equivalent) received 2 weeks prior to starting IMA401 therapy - Patients with active brain metastases |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Immatics Biotechnologies GmbH | Bristol-Myers Squibb |
Germany,
| 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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