RECRUITING

Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas

Conditions

Neuroendocrine Carcinomas Neuroendocrine Tumors Carcinoma, Neuroendocrine Carcinoma, Adrenocortical Carcinoma, Adrenal Cortical Pheochromocytoma Neuroblastoma Neuroendocrine Tumor Neuroendocrine carcinoma Neuroendocrine neoplasms Paraganglioma Adrenocortical Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas

Quick Facts

Study Start:2024-06-17

Study Completion:2029-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06041516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC). * Locally advanced or metastatic disease (as confirmed by a radiological evaluation). * Participants must have measurable disease per RECIST 1.1. * Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). * Age \>= 18 years. * ECOG performance status \<= 2. * Adequate hematologic function as follows: * Leukocytes \>= 3,000/microliter * Absolute neutrophil count (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 (Chronic Kidney Disease Epidemiology Collaboration (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 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN, (unless liver metastases are present, then values must be \<= 5 x ULN). * Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load. * Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral deoxyribonucleic acid (DNA) load must be \<2000 IU/mL. * Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \>= 200 cells per cubic millimeter. * Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms. * Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 9.5 months after the last dose of the ADCT-701 (restriction period). * Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6.5 months after study treatment discontinuation. * Participants must be able to understand and be willing to sign a written informed consent document.	* Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation. * Participants taking any herbal supplements within 14 days prior to treatment initiation. * Participants who have wound dehiscence from prior surgeries. * Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requires drainage or is associated with shortness of breath) at screening. * Active infection requiring systemic antibiotic therapy at screening. * Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target international normalized ratio (INR) \> 2 at screening. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug. * An active autoimmune disease. Note: Participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\<= the equivalent of prednisone 10 mg/day), or other mild autoimmune disorders (Type 1 diabetes, eczema, vitiligo, alopecia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, adrenal insufficiency due to Addison s disease, hypothyroidisms due to Hashimoto s thyroiditis, hyperthyroidisms due to Graves disease, Sjogren s syndrome, celiac disease, pernicious anemia) not requiring immunosuppressive treatment are eligible. * Congenital long QT syndrome, or a corrected QTcF interval of \>=480 ms, at screening (unless secondary to the pacemaker or bundle branch block). * Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care. * Live vaccine administration within 30 days prior to treatment initiation. * Pregnant women (confirmed by Beta-Human Chorionic Gonadotropin \[Beta-HCG\] serum or urine pregnancy test) performed at screening. * Uncontrolled intercurrent illness that would limit compliance with study requirements.

Inclusion Criteria

Exclusion Criteria

* Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC).
* Locally advanced or metastatic disease (as confirmed by a radiological evaluation).
* Participants must have measurable disease per RECIST 1.1.
* Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s).
* Age \>= 18 years.
* ECOG performance status \<= 2.
* Adequate hematologic function as follows:
* Leukocytes \>= 3,000/microliter
* Absolute neutrophil count (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 (Chronic Kidney Disease Epidemiology Collaboration (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
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN, (unless liver metastases are present, then values must be \<= 5 x ULN).
* Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load.
* Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral deoxyribonucleic acid (DNA) load must be \<2000 IU/mL.
* Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \>= 200 cells per cubic millimeter.
* Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms.
* Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 9.5 months after the last dose of the ADCT-701 (restriction period).
* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6.5 months after study treatment discontinuation.
* Participants must be able to understand and be willing to sign a written informed consent document.

* Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation.
* Participants taking any herbal supplements within 14 days prior to treatment initiation.
* Participants who have wound dehiscence from prior surgeries.
* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requires drainage or is associated with shortness of breath) at screening.
* Active infection requiring systemic antibiotic therapy at screening.
* Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target international normalized ratio (INR) \> 2 at screening.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.
* An active autoimmune disease. Note: Participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\<= the equivalent of prednisone 10 mg/day), or other mild autoimmune disorders (Type 1 diabetes, eczema, vitiligo, alopecia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, adrenal insufficiency due to Addison s disease, hypothyroidisms due to Hashimoto s thyroiditis, hyperthyroidisms due to Graves disease, Sjogren s syndrome, celiac disease, pernicious anemia) not requiring immunosuppressive treatment are eligible.
* Congenital long QT syndrome, or a corrected QTcF interval of \>=480 ms, at screening (unless secondary to the pacemaker or bundle branch block).
* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care.
* Live vaccine administration within 30 days prior to treatment initiation.
* Pregnant women (confirmed by Beta-Human Chorionic Gonadotropin \[Beta-HCG\] serum or urine pregnancy test) performed at screening.
* Uncontrolled intercurrent illness that would limit compliance with study requirements.

Contacts and Locations

Study Contact

Kimberley J Cooper

CONTACT

(240) 858-7989

kimberley.cooper@nih.gov

Jaydira Del Rivero, M.D.

CONTACT

(240) 858-3851

delriveroj@mail.nih.gov

Principal Investigator

Jaydira Del Rivero, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Jaydira Del Rivero, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17

Study Completion Date2029-10-30

Study Record Updates

Study Start Date2024-06-17

Study Completion Date2029-10-30

Terms related to this study

Keywords Provided by Researchers

Pheochromocytoma
Neuroblastoma
Neuroendocrine Tumor
Neuroendocrine carcinoma
Neuroendocrine neoplasms
Paraganglioma
Adrenocortical Carcinoma

Additional Relevant MeSH Terms

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