Subcategory
Breast cancer, Melanoma, Non-small cell lung cancer (NSCLC), Urothelial carcinoma of the urinary bladder (incl. renal pelvis, ureter)
Trial Type
Follow-Up Treatment (Metastatic Disease)
Description for experts
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
Description for laymen
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.
JSON Data
{
"short_title": "IMA401-101 - therapeutisch",
"data_mode": "900",
"data_mode_number": "000002232",
"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\u00c2\u00ae), in Patients With Recurrent and/or Refractory Solid Tumors.",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "gtThird",
"ctgov_number": "NCT05359445",
"eudract_number": "2021-004326-30",
"general_contact_email": null,
"general_contact_phone": null,
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Eine erste klinische Studie der Phase Ia/Ib zur Bewertung der Sicherheit, Vertr\u00e4glichkeit und anf\u00e4nglichen Anti-Tumor-Aktivit\u00e4t von IMA401, einem bispezifischen T-Zell-aktivierenden Rezeptormolek\u00fcl (TCER\u00ae), bei Patienten mit wiederkehrenden und/oder refrakt\u00e4ren soliden Tumoren.",
"description_laie_en": "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\u00ae), in Patients With Recurrent and/or Refractory Solid Tumors.",
"description_expert_de": "Eine erste klinische Studie der Phase Ia/Ib zur Bewertung der Sicherheit, Vertr\u00e4glichkeit und anf\u00e4nglichen Anti-Tumor-Aktivit\u00e4t von IMA401, einem bispezifischen T-Zell-aktivierenden Rezeptormolek\u00fcl (TCER\u00ae), bei Patienten mit wiederkehrenden und/oder refrakt\u00e4ren soliden Tumoren.",
"description_expert_en": "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",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I_II",
"main_cat_id": 11,
"sub_cat_id": 52
}
