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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06041516
Phase
PHASE1
Status
Recruiting
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Conditions

  • Carcinoma, Adrenal Cortical
  • Carcinoma, Adrenocortical
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Carcinomas
  • Neuroendocrine Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • ADCT-701 — DRUG
    ADCT-701 in 2microgram/kg-255microgram/kg (weight based dosing), IV over 30 minutes (+15 minutes)

Study Details

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....

Key Dates

Start date
Jun 17, 2024
Status verified
Mar 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Arm1
    ADCT-701 given as an IV infusion

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) of ADCT-701 [ Time Frame: cycle 1, days 1-21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
National Cancer Institute Medical Oncology
[email protected]
888-624-1937
Jaydira Del Rivero, M.D.
[email protected]
(240) 858-3851

Find similar trials in Bethesda, MD

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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