BridgeMD
New treatment option for Neuroendocrine Carcinomas
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
ClinicalTrials.gov ID: NCT06041516
What this study is testing
What is ADCT-701?
ADCT-701 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for neuroendocrine carcinomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant...
- Locally advanced, unresectable 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). Note: Patients...
- Age \>= 18 years.
You likely can't join if
- Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy...
- 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...
- 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...
See the full eligibility criteria
- Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST).
- Locally advanced, unresectable 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). Note: Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment...
- 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...
- 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.
- Individuals of child-bearing potential (IOCBP) 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...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 6.5 months after study treatment discontinuation.
- Participants or legally authorized representative (LAR) 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 half-lives, whichever is shorter, prior to...
- 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...
- 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...
- Live vaccine administration within 30 days prior to treatment initiation.
- Pregnant individuals (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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.