Radioactive antibody aims to light up hidden solid tumors

NCT ID NCT07815951

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing a new imaging agent called 111In-TJD-31 that targets placental alkaline phosphatase (ALPP), a protein found on many solid tumor cells but rarely in healthy adult tissue. The study enrolls 8 participants: 2 healthy volunteers who give blood samples and 6 patients with confirmed solid tumors who receive a single intravenous injection and then undergo SPECT/CT scans. The goal is to see whether the tracer safely reaches tumors and shows up clearly on images, while also measuring how it moves through the body and how much radiation it delivers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
111In-TJD-31, an experimental SPECT imaging tracer made of a humanized antibody linked to radioactive indium-111
What this could lead to
If it works, this tracer could give doctors another way to spot solid tumors on scans, including cancers that are hard to see with standard imaging.
What could go wrong
This is a first-in-human Phase 1 study with only 8 participants, so it cannot prove the tracer improves diagnosis. The tracer may not accumulate in tumors well enough to be useful, and radiation exposure and infusion reactions are possible risks.

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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 8 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * For Patients with Solid Tumors: 1. Voluntary signed written informed consent before any study-specific procedures; 2. Clinically highly suspected or histologically (or cytologically) confirmed malignant solid tumors with measurable lesions (target lesions), including treatment-naïve and relapsed patients; 3. Age ≥18 and ≤75 years, male or female; 4. ECOG performance status 0 or 1; 5. Life expectancy ≥6 months; 6. Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration. For Healthy Volunteers: 1. Chinese healthy volunteers, male or female; 2. Age 18 to 55 years (inclusive); 3. Body weight: females 45-80 kg (inclusive), males 50-80 kg (inclusive); 4. Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration; 5. Ability to communicate well with the investigator, understand and comply with all study requirements, and voluntarily sign informed consent before any study-related procedures. Exclusion Criteria: * For Patients with Solid Tumors: 1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration; 2. Known or suspected allergy to the study drug or any of its components; 3. Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer; 4. Use of any radiotherapeutic agent within 90 days prior to study drug administration, or use of any radionuclide diagnostic agent within 3 days prior to study drug administration; 5. Significant hepatic or renal dysfunction: serum total bilirubin \>1.5 × upper limit of normal (ULN), or AST and/or ALT \>2.5 × ULN, or serum creatinine \>1.5 × ULN; 6. Active infection at screening; 7. Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging; 8. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study. For Healthy Volunteers: 1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration; 2. Known or suspected allergy to the study drug or any of its components; 3. Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer; 4. Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening; 5. History of any clinically significant disease (including but not limited to cardiac, hepatic, renal, digestive, biliary, endocrine, cardiovascular, neurological, psychiatric, respiratory, immunological, hematological, hematopoietic, or urinary system disease) within 4 weeks prior to screening, as judged by the investigator; 6. Blood pressure \>150/100 mmHg or \<90/50 mmHg at screening; 7. Use of any prescription or over-the-counter medication (including herbal medicines, dietary supplements, and vitamins, except for routine continuous vitamin use) within 2 weeks prior to study drug administration, unless judged by the investigator as not affecting the study results; 8. Blood donation or blood loss ≥500 mL within 12 weeks prior to study drug administration; 9. History of any malignant tumor; 10. Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging; 11. Any other condition that, in the investigator's opinion, makes the volunteer unsuitable for the 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

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

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