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

RT01-89Zr is a TF-targeting radiopharmaceutical diagnostic agent. This trial aims to evaluate the safety, biodistribution, dosimetry, and imaging characteristics of RT01-89Zr as a PET/CT tracer in patients with malignant solid tumors that highly express the TF target.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: RT01-89Zr

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jingchun Yu; Phone Number: 0510-68089404; Email: ycjwxd1978@jiangnan.edu.cn

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214122
      • Recruiting
      • Affiliated Hospital of Jiangnan University
      • Contact: Jingchun Yu; Phone Number: 0510-68089404; Email: kjc68088861@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT01-89Zr	Drug: RT01-89Zr; Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	The number and percentage of patients with adverse events/serious adverse events	Within 21 days after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological distribution	Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images	through study completion, an average of 3 months
Radiation Dosimetry	Calculate the radiation-absorbed dose of each organ and lesion and the whole-body effective dose using the MIRD method	through study completion, an average of 3 months
Visual Analysis	Image visual score 0-3 (0 no obvious uptake, 1 slightly above background, 2 above background, 3 significantly above background)	through study completion, an average of 3 months
Semi-quantitative analysis	Standard uptake values (SUVmax, SUVmean)	through study completion, an average of 3 months
Probe Targeting Performance Analysis	The sensitivity (positive rate) of RT01-89Zr PET/CT in patients with solid tumors	through study completion, an average of 3 months
Biological distribution	Retention time of each organ of interest through RT01-89Zr PET/CT images	through study completion, an average of 3 months
Biological distribution	Standard uptake value(SUV) of each organ of interest through RT01-89Zr PET/CT images	through study completion, an average of 3 months
Semi-quantitative analysis	Target-to-background ratio (TBR) (background can include mediastinum, general background, liver, muscle);	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Nanolattix Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QM-RT01-2551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No