Imaging tissue-factor–positive solid tumors with RT01-89Zr PET/CT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase 1 interventional trial that gives RT01-89Zr, a tissue-factor–targeting radiopharmaceutical, and uses PET/CT to characterize safety, biodistribution, dosimetry, and imaging properties in patients with malignant solid tumors. Eligible participants are adults (18–75 years) with confirmed solid tumors and tumor tissue showing >1% target expression, and they must be able to undergo PET/CT imaging. The protocol includes administration of the tracer, serial PET/CT scans to map tracer uptake, and safety monitoring including adverse event and radiation dosimetry assessments. Tumor tissue (archived or fresh biopsy) is required for target-expression confirmation prior to imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients of either gender, ages 18-75 (including 18 and 75);
* ECOG Performance Status: 0 or 1;
* Confirmed as a solid tumor by histopathology or cytology;
* At least one primary or metastatic lesion confirmed by conventional imaging；
* During the screening period, tumor tissue samples (either archived previously or freshly biopsied) can be provided, with positive target expression of more than 1%;
* Voluntarily participate in this study and sign a written informed consent form, agree to comply with the research procedures, and cooperate throughout the entire research process;
* Women of childbearing potential must have a negative pregnancy test result. If the patient is of childbearing potential, she must agree to abstain from sexual activity or use highly effective contraception from the time of signing the informed consent until 3 months after the administration of the investigational drug;

Exclusion Criteria:

* Patients who are unable to complete a PET/CT scan (including those who cannot lie flat, have claustrophobia, or have fear of radiation, etc.);
* Those who have received radiopharmaceuticals before administration and whose discontinuation duration does not exceed 5 half-lives;
* Participants who have participated in other clinical trials within the past 3 months (except for clinical trials of investigational drugs discontinued for more than 5 half-lives, and assessed by the investigator as having no impact on endpoint evaluation and participant safety), or who plan to participate during the trial;
* Acute systemic diseases and electrolyte disorders;
* Patients known to be allergic to the RT01 contrast agent or synthetic excipients;
* Researchers believe that patients with poor adherence;
* Patients who are pregnant or breastfeeding;
* Other factors that render the patient unsuitable for trial participation..

Where it's running

• Affiliated Hospital of Jiangnan University
  Wuxi, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jingchun Yu
• Email: ycjwxd1978@jiangnan.edu.cn
• Phone: 0510-68089404

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• REC-7735 for PIK3CA-H1047R-mutant solid tumors

  This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.

  Recruiting at 3 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Grand Rapids, Michigan and 2 other locations · NCT07819136

• Preferences of physicians and patients for cell therapies in advanced solid tumors

  This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

• HP007 monotherapy for relapsed or advanced solid tumors

  This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.

  Recruiting Phase 1 Parr Biotechnology (Hebei) Co., Ltd. · Changchun, Jilin · NCT07800936

• ONO-7429 in advanced or recurrent solid tumors

  This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.

  Recruiting at 10 sites Phase 1 Ono Pharmaceutical Co., Ltd. · Kashiwa, Chiba and 9 other locations · NCT07787208

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.