Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas : A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas
Background:-Neuroendocrine neoplasms (NENs) are divided into neuroendocrine tumors (NETs) and neuroendocrine carcinomas (NECs). These are rare malignancies occurring in areas such as the gastrointestinal tract, islets of the pancreas, lung, adrenal gland, and other areas ofthe body.Poorly differentiated neuroendocrine carcinomas are all high-grade carcinomas that resemble small-cell lung cancer (SCLC). Poorly differentiated NECs are also treated with platinum-based regimens in accordance with small cell carcinoma guidelines and have a high risk of relapse as well as a poor response to further systemic therapies.Adrenocortical carcinoma (ACC) is a rare malignancy with an average survival from the time of diagnosis of 14.5 months. In advanced diseases, chemotherapy options have limited benefits. To date, no "targeted therapy" has been shown to have significant efficacy in this disease.Pre-clinical studies have shown that Delta-like non-canonical notch ligand 1 (DLK1) is expressed in multiple neuroendocrine neoplasms such as ACC, SCLC, neuroblastoma, pheochromocytoma, and paraganglioma.ADCT-701 a humanized antibody directed against DLK1 effectively suppresses tumor growth and improves survival in multiple cancer models which express DLK1.Objective:-To determine the maximum tolerated dose (MTD) of ADCT-701 in participants with neuroendocrine neoplasms or malignant adrenocortical carcinomaEligibility:Histologically or cytologically confirmed neuroendocrine neoplasms or malignant ACC.Age >= 18 years.Evaluable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.Adequate organ and bone marrow function.Eastern Cooperative Oncology Group (ECOG) <= 2.Design:This is a First in Human phase I dose escalation study of ADCT-701-single agent in participants with NENs.Participants will be enrolled in a dose-finding trial. A 3+3 design with up to ten dose levels of ADCT-701 will be evaluated in this trial. The study drug dose will be escalated unless the occurrence of dose-limiting toxicities limits further escalation or until the maximum tolerated dose level is reached or an optimal dose is determined.Up to 70 evaluable patients will be enrolled over a maximum of 10 dose levels..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 02. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: September 18, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
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| Study ID: |
NCT06041516 |
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| PPN (Katalog-ID): |
CTG000015032 |
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| 245 | 1 | 0 | |a Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas |b A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas |
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| 520 | |a Background:-Neuroendocrine neoplasms (NENs) are divided into neuroendocrine tumors (NETs) and neuroendocrine carcinomas (NECs). These are rare malignancies occurring in areas such as the gastrointestinal tract, islets of the pancreas, lung, adrenal gland, and other areas ofthe body.Poorly differentiated neuroendocrine carcinomas are all high-grade carcinomas that resemble small-cell lung cancer (SCLC). Poorly differentiated NECs are also treated with platinum-based regimens in accordance with small cell carcinoma guidelines and have a high risk of relapse as well as a poor response to further systemic therapies.Adrenocortical carcinoma (ACC) is a rare malignancy with an average survival from the time of diagnosis of 14.5 months. In advanced diseases, chemotherapy options have limited benefits. To date, no "targeted therapy" has been shown to have significant efficacy in this disease.Pre-clinical studies have shown that Delta-like non-canonical notch ligand 1 (DLK1) is expressed in multiple neuroendocrine neoplasms such as ACC, SCLC, neuroblastoma, pheochromocytoma, and paraganglioma.ADCT-701 a humanized antibody directed against DLK1 effectively suppresses tumor growth and improves survival in multiple cancer models which express DLK1.Objective:-To determine the maximum tolerated dose (MTD) of ADCT-701 in participants with neuroendocrine neoplasms or malignant adrenocortical carcinomaEligibility:Histologically or cytologically confirmed neuroendocrine neoplasms or malignant ACC.Age >= 18 years.Evaluable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.Adequate organ and bone marrow function.Eastern Cooperative Oncology Group (ECOG) <= 2.Design:This is a First in Human phase I dose escalation study of ADCT-701-single agent in participants with NENs.Participants will be enrolled in a dose-finding trial. A 3+3 design with up to ten dose levels of ADCT-701 will be evaluated in this trial. The study drug dose will be escalated unless the occurrence of dose-limiting toxicities limits further escalation or until the maximum tolerated dose level is reached or an optimal dose is determined.Up to 70 evaluable patients will be enrolled over a maximum of 10 dose levels. | ||
| 650 | 2 | |a Carcinoma | |
| 650 | 2 | |a Neuroendocrine Tumors | |
| 650 | 2 | |a Carcinoma, Neuroendocrine | |
| 650 | 2 | |a Adrenocortical Carcinoma | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
| 650 | 4 | |a Phase: Phase 1 | |
| 650 | 4 | |a 610 | |
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