Actively Recruiting
A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-03-27
70
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed neuroendocrine neoplasms, malignant adrenocortical carcinoma (ACC), or malignant peripheral nerve sheath tumors (MPNST)
- Locally advanced, unresectable, or metastatic disease confirmed by imaging
- Measurable disease according to RECIST 1.1 criteria
- Prior standard treatment received and refractory or intolerant to these therapies (MPNST patients who refused chemotherapy or are treated before chemotherapy may also be eligible)
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate blood cell counts: leukocytes ≥ 3,000/microliter, ANC ≥ 1,200/microliter (off growth factors for 72 hours), hemoglobin ≥ 9 g/dL without recent transfusions, platelets ≥ 100,000/microliter without recent transfusions
- Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min/1.73 m², bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3.0 x ULN if Gilbert's syndrome, ALT and AST ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases present)
- Negative or well-controlled hepatitis C virus (HCV) infection
- Hepatitis B virus (HBV) positive participants must be on antiviral therapy with low viral load (<2000 IU/mL)
- HIV-positive participants must be on stable therapy, with no recent opportunistic infections, undetectable viral load, and CD4 count ≥ 200 cells/mm³
- Participants with brain metastases must be stable for at least 4 weeks after treatment with no progression or symptoms
- Individuals able and willing to use effective contraception during and after the study (males and females as specified)
- Nursing participants willing to stop nursing during treatment and follow-up
- Ability to understand and sign informed consent
You will not qualify if you...
- Major surgery, chemotherapy, hormonal therapy, immunotherapy, investigational treatment, or radiation within 4 weeks or 5 half-lives before treatment
- Use of herbal supplements within 14 days before treatment
- Wounds from previous surgeries that have not healed (wound dehiscence)
- Significant fluid buildup requiring drainage or causing breathing problems
- Active infections needing antibiotics
- Active bleeding disorders or use of blood thinning medication with high INR (>2)
- History of allergic reactions to similar drugs
- Active autoimmune diseases requiring immunosuppressive treatment (some mild autoimmune conditions allowed)
- Congenital long QT syndrome or prolonged QT interval on heart monitoring
- Active second primary cancers needing treatment (except certain low-risk cancers)
- Live vaccines given within 30 days before treatment
- Pregnancy confirmed by test at screening
- Uncontrolled illnesses that would prevent following study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anna Liza F Rivero
CONTACT
J
Jaydira Del Rivero, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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