Category
Gastrointestinal tumors, Gynecological tumors / Breast cancer, Thoracic tumors
Subcategory
Pancreatic cancer, Colorectal cancer, Breast cancer, Non-small cell lung cancer (NSCLC)
Trial Type
other systemic therapies
Description for experts
The primary objective of this study is to:
Evaluate the safety and tolerability of AMG 305 in adult participants
Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
Determine the recommended phase 2 dose (RP2D)
Description for laymen
Evaluate the safety and tolerability of AMG 305 in adult participants , determine the optimal biologically active dose (OBD) that is at or below the maximum tolerated dose (MTD), where MTD 1 is the maximum tolerated starting dose and MTD 2 is the maximum tolerated target dose Determination of the recommended phase 2 dose (RP2D).
JSON Data
{
"short_title": "AMG305_20220073",
"data_mode": "900",
"data_mode_number": "000002275",
"official_title": "Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors. ",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": "NCT05800964",
"eudract_number": "2022-502867-39",
"general_contact_email": "ectu@ukdd.de",
"general_contact_phone": "+49 351-4587566",
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Bewertung der Sicherheit und Vertr\u00e4glichkeit von AMG 305 bei erwachsenen Teilnehmern , Bestimmung der optimalen biologisch aktiven Dosis (OBD), die bei oder unter der maximal vertr\u00e4glichen Dosis (MTD) liegt, wobei MTD 1 die maximal vertr\u00e4gliche Anfangsdosis und MTD 2 die maximal vertr\u00e4gliche Zieldosis darstellt\r\nBestimmung der empfohlenen Phase-2-Dosis (RP2D).",
"description_laie_en": "Evaluate the safety and tolerability of AMG 305 in adult participants , determine the optimal biologically active dose (OBD) that is at or below the maximum tolerated dose (MTD), where MTD 1 is the maximum tolerated starting dose and MTD 2 is the maximum tolerated target dose Determination of the recommended phase 2 dose (RP2D).",
"description_expert_de": null,
"description_expert_en": "The primary objective of this study is to:\r\n\r\nEvaluate the safety and tolerability of AMG 305 in adult participants\r\nDetermine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose\r\nDetermine the recommended phase 2 dose (RP2D)",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I",
"main_cat_id": 10,
"sub_cat_id": 50
}
