Identification of the Notch ligand DLK1 as an immunotherapeutic target and regulator of tumor cell plasticity and chemoresistance in adrenocortical carcinoma.
Nai-Yun Sun, Suresh Kumar, Yoo Sun Kim...
https://pubmed.ncbi.nlm.nih.gov/40595495Actively Recruiting
Phase 1
Age: 18Years - 120Years
All Genders
ID06041516
A First-in-Human Phase I Trial of 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a new drug called ADCT-701 in adults with neuroendocrine neoplasms (NENs), including rare cancers found in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas. These cancers often have a high risk of returning and low survival rates, and current treatments have limited benefits. The study is a first-in-human Phase I trial designed to find the maximum tolerated dose of ADCT-701, a drug targeting DLK1, which is present in various neuroendocrine tumors and related cancers. Participants will receive ADCT-701 as an intravenous infusion over 30 to 45 minutes on the first day of each 21-day treatment cycle. The study uses a dose-escalation design to determine the best dose, with up to 10 dose levels tested in approximately 70 patients. Treatment can continue for up to two years. After completing treatment, participants will have follow-up visits including physical exams, heart and blood tests, and imaging scans for up to five years to monitor health and disease status. During the study, participants will undergo screening that includes physical exams, blood and urine tests, imaging scans, heart function tests, and possibly a tumor biopsy. Clinic visits are frequent at first, with 10 visits over the first two cycles, then two visits per cycle thereafter. Each visit may last up to eight hours and includes repeated tests and assessments of daily activity ability. Researchers will monitor safety, drug levels in the body, immune responses, and antitumor activity throughout the trial and follow-up periods.
CONDITIONS
Brief 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
Age: 18Years - 120Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed neuroendocrine neoplasms, malignant adrenocortical carcinoma, or malignant peripheral nerve sheath tumors
- Locally advanced, unresectable, or metastatic disease confirmed by radiology
- Measurable disease according to RECIST 1.1
- Age 18 years or older
- ECOG performance status of 2 or less
- Adequate blood counts: leukocytes ≥ 3,000/microliter, ANC ≥ 1,200/microliter, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/microliter
- Adequate kidney and liver function as specified
- Negative or controlled hepatitis B, hepatitis C, and HIV infections as described
- Brain metastases allowed if stable and treated at least 4 weeks prior
- Use of effective contraception for individuals of child-bearing potential during and after treatment
- Willingness to discontinue nursing during treatment and up to 6.5 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Major surgery, chemotherapy, hormonal therapy, immunotherapy, investigational agents, or radiation therapy within 4 weeks or 5 half-lives before treatment
- Use of herbal supplements within 14 days before treatment
- Wound healing problems from prior surgeries
- Significant fluid buildup requiring drainage or causing breathing issues
- Active infection needing antibiotics at screening
- Active bleeding disorders or high anticoagulation levels
- Allergic reactions to similar compounds as the study drug
- Active autoimmune diseases requiring immunosuppressive treatment
- Congenital long QT syndrome or prolonged QTc interval
- Active second cancers requiring treatment, except certain non-invasive or non-metastatic cancers
- Live vaccine within 30 days before treatment
- Pregnancy confirmed by pregnancy test
- Uncontrolled illnesses that interfere with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - Repeated 21-day cycles until dose-limiting toxicities occur or maximum tolerated dose is reached
Participants receive ADCT-701 as an intravenous infusion to determine the maximum tolerated dose of the drug.
Multiple visits for drug infusions and assessments per cycle
Follow-up
Duration - Up to 5 years
Participants are monitored for safety, anti-tumor activity, pharmacokinetics, and immunogenicity after treatment ends.
Periodic visits for up to 5 years after last infusion
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
A
Anna Liza F Rivero
J
Jaydira Del Rivero, M.D.
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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Published Research Related To This Trial
Identification of DLK1, a Notch ligand, as an immunotherapeutic target and regulator of tumor cell plasticity and chemoresistance in adrenocortical carcinoma.
Nai-Yun Sun, Suresh Kumar, Yoo Sun Kim...
https://pubmed.ncbi.nlm.nih.gov/39416174