OncoMatch/Clinical Trials/NCT06041516
A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors
Is NCT06041516 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ADCT-701 for neuroendocrine carcinomas.
Treatment: ADCT-701 — 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....
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care therapy
Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). Note: Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest for the patient by the local investigator and treating investigator will also be eligible.
Cannot have received: chemotherapy
Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.
Cannot have received: hormonal therapy
Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.
Cannot have received: immunotherapy
Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.
Cannot have received: investigational agent
Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.
Cannot have received: radiation therapy
Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.
Lab requirements
Blood counts
Leukocytes >= 3,000/microliter; ANC >= 1,200/microliter (off-growth factors for 72 hours prior to treatment initiation); Hemoglobin (Hgb) >= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation; Platelets >= 100,000/microliter with no platelet transfusion within 1 week.
Kidney function
Creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 (calculated CrCl (CKD-EPI) or calculated eGFR provided by a laboratory)
Liver function
Total bilirubin <= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin <= 3.0 x ULN; ALT and AST <= 2.5 x ULN, unless liver metastases are present, then values must be <= 5 x ULN.
Adequate hematologic function as follows: Leukocytes >= 3,000/microliter; ANC >= 1,200/microliter (off-growth factors for 72 hours prior to treatment initiation); Hemoglobin (Hgb) >= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation; Platelets >= 100,000/microliter with no platelet transfusion within 1 week. Adequate renal and hepatic function as follows: Creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 (calculated CrCl (CKD-EPI) or calculated eGFR provided by a laboratory); Total bilirubin <= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin <= 3.0 x ULN; ALT and AST <= 2.5 x ULN, unless liver metastases are present, then values must be <= 5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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