New radioactive drug shows promise for Hard-to-Treat cancers

NCT ID NCT07439120

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new radioactive drug (BRP-020063) in 10 people with advanced solid tumors that have spread. The drug is used first for imaging to find tumors, then a low dose is given to see if it's safe and how it travels in the body. The goal is to gather information for future, higher-dose treatment studies.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Started

Apr 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: 1. Age ≥ 18 years, regardless of gender; 2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer); 3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years); 4. Performance status (ECOG) score of 0-1; 5. Adequate organ function: * Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L; * Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN; * Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); * Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN; 6. Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females); 7. Willing to participate in this trial and sign an informed consent form. Exclusion Criteria: 1. Previous treatment with Nectin-4-targeted drugs (including clinical trials); 2. Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.); 3. Participation in drug or device clinical studies within 4 weeks prior to the first dose; 4. Presence of severe or uncontrolled underlying diseases, including but not limited to: 1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication; 2. Severe cardiovascular/cerebrovascular or valvular diseases; 3. Poorly controlled diabetes or hypertension; 5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia); 6. Active infection within 4 weeks prior to the first dose; 7. Women who are planning pregnancy, currently pregnant, or breastfeeding; 8. Allergy to radioactive rays or other severe allergic history; 9. History of neurological metastasis with associated symptoms; 10. Concurrent other malignancies; 11. Undergone general anesthesia surgery within 4 weeks prior to the first dose; 12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.

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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

  • Shanghai General Hospital

    RECRUITING

    Shanghai, China

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