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

Summary

Background: Neuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed. Objective: To test a new drug, ADCT-701, in people with NENs. Eligibility: Adults aged 18 and older with NENs. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of heart functioning. Their ability to perform normal daily activities will be tested. A biopsy may be needed: A sample of tissue will be removed from the tumor. ADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive the drug treatment on the first day of 21-day treatment cycles. They will visit the clinic a total of 10 times during the first two cycles. After that, they will visit the clinic 2 times during each cycle. Imaging scans, blood draws, heart function tests, and other tests will be repeated during study visits. Each visit will last up to 8 hours. Participants may continue receiving treatment with the study drug for up to 2 years. After treatment ends, participants will have follow-up clinic visits 4 times in 4 months. They will have a physical exam, with heart and blood tests, at each visit. After that, they will have follow-up clinic visits every 9 weeks; these visits will include imaging scans. Follow-up visits will continue for up to 5 years after treatment began....

Timeline

Start

2024-06-17

Primary completion

2027-10-30

Completion

2029-10-30

Publications

• Sun NY, Kumar S, Kim YS, Varghese D, Mendoza A, Nguyen R, Okada R, Reilly K, Widemann B, Pommier Y, Elloumi F, Dhall A, Taniyama D, Patel M, Aber E, Contreras CF, Kaplan RN, Kiseljak-Vassiliades K, Wierman ME, Martinez D, Pogoriler J, Hamilton AK, Diskin SJ, Maris JM, Robey RW, Gottesman MM, Del Rivero J, Roper N. Identification of the Notch ligand DLK1 as an immunotherapeutic target and regulator of tumor cell plasticity and chemoresistance in adrenocortical carcinoma. Nat Commun. 2025 Jul 1;16(1):5511. doi: 10.1038/s41467-025-60649-w.
• Sun NY, Kumar S, Kim YS, Varghese D, Mendoza A, Nguyen R, Okada R, Reilly K, Widemann B, Pommier Y, Elloumi F, Dhall A, Patel M, Aber E, Contreras-Burrola C, Kaplan R, Martinez D, Pogoriler J, Hamilton AK, Diskin SJ, Maris JM, Robey RW, Gottesman MM, Rivero JD, Roper N. Identification of DLK1, a Notch ligand, as an immunotherapeutic target and regulator of tumor cell plasticity and chemoresistance in adrenocortical carcinoma. bioRxiv [Preprint]. 2024 Oct 11:2024.10.09.617077. doi: 10.1101/2024.10.09.617077.

Drugs

Indications