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

Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors

This study will try a new PET/CT imaging agent called RT01-89Zr in adults with solid tumors that show tissue factor on tumor tests.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanolattix Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT07505069 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed malignant solid tumors, ECOG 0–1, at least one lesion on conventional imaging, and tumor tissue showing >1% tissue factor expression who can undergo PET/CT and provide informed consent.

Not a fit: Patients whose tumors lack tissue factor expression, who cannot complete PET/CT scans, who have poor performance status, or who are pregnant are unlikely to receive benefit from this imaging agent.

Why it matters

Potential benefit: If successful, RT01-89Zr could help doctors see tissue-factor–expressing tumors more clearly and better select patients for targeted therapies or follow-up imaging.

How similar studies have performed: Other 89Zr-labeled antibody PET tracers have successfully imaged targets in humans, but targeting tissue factor with RT01-89Zr is relatively novel and has limited prior clinical data.

Eligibility criteria

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 this trial is running

Wuxi, Jiangsu

• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jingchun Yu

Conditions Solid Tumors