A First-in-Human Phase I Trial of Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas, and Malignant Peripheral Nerve Sheath Tumors

What this Trial Is About

This research aims to evaluate a new drug called ADCT-701 in adults with neuroendocrine neoplasms NENs, including rare cancers found in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas. These cancers often have a high risk of returning and low survival rates, and current treatments have limited benefits. The study is a first-in-human Phase I trial designed to find the maximum tolerated dose of ADCT-701, a drug targeting DLK1, which is present in various neuroendocrine tumors and related cancers. Participants will receive ADCT-701 as an intravenous infusion over 30 to 45 minutes on the first day of each 21-day treatment cycle. The study uses a dose-escalation design to determine the best dose, with up to 10 dose levels tested in approximately 70 patients. Treatment can continue for up to two years. After completing treatment, participants will have follow-up visits including physical exams, heart and blood tests, and imaging scans for up to five years to monitor health and disease status. During the study, participants will undergo screening that includes physical exams, blood and urine tests, imaging scans, heart function tests, and possibly a tumor biopsy. Clinic visits are frequent at first, with 10 visits over the first two cycles, then two visits per cycle thereafter. Each visit may last up to eight hours and includes repeated tests and assessments of daily activity ability. Researchers will monitor safety, drug levels in the body, immune responses, and antitumor activity throughout the trial and follow-up periods.

A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors