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New hope for rare cancers: experimental drug ADCT-701 enters human trials

NCT ID NCT06041516

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called ADCT-701 in adults with rare cancers like neuroendocrine tumors, adrenal cancer, and malignant peripheral nerve sheath tumors. The goal is to find the safest dose and see if it can shrink tumors or slow disease. Participants receive the drug through an IV every 3 weeks and are monitored closely for up to 2 years of treatment and 5 years of follow-up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION 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 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. * 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. * 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 9.5 months after the last dose of the ADCT-701 (restriction period). Individuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 6.5 months after the last dose of the ADCT-701. * 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. EXCLUSION CRITERIA: * 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. * 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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.