Phase I Trial Testing ADCT-701 Antibody Drug Conjugate for Adults with Neuroendocrine and Related Tumors

What this Trial Is About

Neuroendocrine neoplasms NENs are rare cancers found in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other body areas. These cancers often have a high risk of returning and a low chance of survival. This trial is a Phase I study to test a new drug called ADCT-701 in adults with NENs, malignant adrenocortical carcinoma ACC, or malignant peripheral nerve sheath tumors MPNST. The study aims to find the maximum tolerated dose of ADCT-701 and evaluate its safety and preliminary anti-tumor activity. Participants will receive ADCT-701 as an intravenous infusion once every 21 days in treatment cycles. The drug dose will be gradually increased to find the best dose while monitoring for side effects. During the first two cycles, participants will visit the clinic 10 times, with fewer visits in later cycles. Treatment may continue for up to two years. After treatment ends, follow-up visits will occur four times over four months, then every nine weeks, continuing for up to five years from the start of treatment. Throughout the study, participants will undergo physical exams, blood and urine tests, imaging scans, heart function tests, and activity assessments. A tumor biopsy may be required. Researchers will monitor participants health, treatment effects, and side effects closely. The primary outcome is determining the maximum tolerated dose during the first treatment cycle. Safety, drug effects, and immune responses will be tracked for up to five years.

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