therapeutisch: IMA402 (bispecific T cell engaging receptor molecule)
https://www.nct-dresden.de/en/trials/900-000002271
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therapeutisch: IMA402 (bispecific T cell engaging receptor molecule)
Section
NCT
Category
Gynecological tumors / Breast cancer, Skin tumors, Sarcoma, Thoracic tumors
Subcategory
Endometrial cancer, Melanoma, Soft tissue sarcomas, Non-small cell lung cancer (NSCLC)
Trial Type
other systemic therapies
Description for experts
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 dose and/or recommended dose for extension for IMA402 (Phase I)
To characterize the safety and tolerability of IMA402 (Phase I/II)
To evaluate anti-tumor activity of IMA402 (Phase II)
Secondary objectives:
To evaluate the initial anti-tumor activity of IMA402 (Phase I)
To evaluate anti-tumor activity of IMA402 (Phase II)
To describe the PK of IMA402 (Phase I/II)
Description for laymen
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 dose and/or recommended dose for extension for IMA402 (Phase I)
To characterize the safety and tolerability of IMA402 (Phase I/II)
To evaluate anti-tumor activity of IMA402 (Phase II)
Secondary objectives:
To evaluate the initial anti-tumor activity of IMA402 (Phase I)
To evaluate anti-tumor activity of IMA402 (Phase II)
To describe the PK of IMA402 (Phase I/II)
JSON Data
{
"short_title": "therapeutisch: IMA402 (bispecific T cell engaging receptor molecule) ",
"data_mode": "900",
"data_mode_number": "000002271",
"official_title": "A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER\u00ae) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors.",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": "NCT05958121",
"eudract_number": "2022-503133-54",
"general_contact_email": "ectu@ukdd.de",
"general_contact_phone": "+49 351-4587566",
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Ziel dieser klinischen Studie ist es, die Sicherheit, Vertr\u00e4glichkeit und Anti-Tumor-Aktivit\u00e4t von IMA402 bei Patienten mit rezidivierenden und/oder refrakt\u00e4ren soliden Tumoren zu untersuchen.\r\n\r\nPrim\u00e4re Ziele:\r\n\r\nBestimmung der maximal vertr\u00e4glichen Dosis und/oder der empfohlenen Dosis f\u00fcr die Verl\u00e4ngerung der Behandlung mit IMA402 (Phase I)\r\nCharakterisierung der Sicherheit und Vertr\u00e4glichkeit von IMA402 (Phase I/II)\r\nBewertung der Anti-Tumor-Aktivit\u00e4t von IMA402 (Phase II)\r\nSekund\u00e4re Ziele:\r\n\r\nBewertung der anf\u00e4nglichen Anti-Tumor-Aktivit\u00e4t von IMA402 (Phase I)\r\nBewertung der Anti-Tumor-Aktivit\u00e4t von IMA402 (Phase II)\r\nBeschreibung der PK von IMA402 (Phase I/II)",
"description_laie_en": "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.\r\n\r\nPrimary objectives:\r\n\r\nTo determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I)\r\nTo characterize the safety and tolerability of IMA402 (Phase I/II)\r\nTo evaluate anti-tumor activity of IMA402 (Phase II)\r\nSecondary objectives:\r\n\r\nTo evaluate the initial anti-tumor activity of IMA402 (Phase I)\r\nTo evaluate anti-tumor activity of IMA402 (Phase II)\r\nTo describe the PK of IMA402 (Phase I/II)",
"description_expert_de": "Ziel dieser klinischen Studie ist es, die Sicherheit, Vertr\u00e4glichkeit und Anti-Tumor-Aktivit\u00e4t von IMA402 bei Patienten mit rezidivierenden und/oder refrakt\u00e4ren soliden Tumoren zu untersuchen.\r\n\r\nPrim\u00e4re Ziele:\r\n\r\nBestimmung der maximal vertr\u00e4glichen Dosis und/oder der empfohlenen Dosis f\u00fcr die Verl\u00e4ngerung der Behandlung mit IMA402 (Phase I)\r\nCharakterisierung der Sicherheit und Vertr\u00e4glichkeit von IMA402 (Phase I/II)\r\nBewertung der Anti-Tumor-Aktivit\u00e4t von IMA402 (Phase II)\r\nSekund\u00e4re Ziele:\r\n\r\nBewertung der anf\u00e4nglichen Anti-Tumor-Aktivit\u00e4t von IMA402 (Phase I)\r\nBewertung der Anti-Tumor-Aktivit\u00e4t von IMA402 (Phase II)\r\nBeschreibung der PK von IMA402 (Phase I/II)",
"description_expert_en": "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.\r\n\r\nPrimary objectives:\r\n\r\nTo determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I)\r\nTo characterize the safety and tolerability of IMA402 (Phase I/II)\r\nTo evaluate anti-tumor activity of IMA402 (Phase II)\r\nSecondary objectives:\r\n\r\nTo evaluate the initial anti-tumor activity of IMA402 (Phase I)\r\nTo evaluate anti-tumor activity of IMA402 (Phase II)\r\nTo describe the PK of IMA402 (Phase I/II)",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I_II",
"main_cat_id": 10,
"sub_cat_id": 50
}