ADCT-701 for Rare Cancers
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have had major surgery, chemotherapy, hormonal therapy, immunotherapy, or radiation therapy within 4 weeks before starting the trial. Also, you should not take any herbal supplements within 14 days before starting the trial.
What safety information is available for ADCT-701 and similar treatments?
Antibody-drug conjugates (ADCs) like ADCT-701 are generally considered safe, but they can cause side effects such as low blood cell counts, liver issues, nerve damage, and eye problems. These side effects are often related to the drug's active components and can vary depending on the specific ADC and cancer type.12345
What is the purpose of this trial?
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....
Research Team
Jaydira Del Rivero, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults over 18 with neuroendocrine tumors or adrenocortical carcinoma, who've tried standard treatments without success. They must have measurable disease, be able to perform daily activities to a certain extent, and agree to use contraception. Excluded are those with recent other cancer treatments, uncontrolled illnesses, certain heart conditions, active infections or allergies related to the study drug.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ADCT-701 through IV infusion on the first day of 21-day treatment cycles. They will visit the clinic 10 times during the first two cycles and 2 times during each subsequent cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 9 weeks including imaging scans.
Treatment Details
Interventions
- ADCT-701
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor