NCT07505069

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
9mo left

Started Jan 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Feb 2027

Study Start

First participant enrolled

January 29, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 10, 2026

Last Update Submit

March 26, 2026

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation

    The number and percentage of patients with adverse events/serious adverse events

    Within 21 days after administration

Secondary Outcomes (8)

  • Biological distribution

    through study completion, an average of 3 months

  • Radiation Dosimetry

    through study completion, an average of 3 months

  • Visual Analysis

    through study completion, an average of 3 months

  • Semi-quantitative analysis

    through study completion, an average of 3 months

  • Probe Targeting Performance Analysis

    through study completion, an average of 3 months

  • +3 more secondary outcomes

Study Arms (1)

RT01-89Zr

EXPERIMENTAL
Drug: RT01-89Zr

Interventions

RT01-89ZrDRUG

Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi

RT01-89Zr

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214122, China

RECRUITING

Central Study Contacts

Jingchun Yu

CONTACT

0510-68089404ycjwxd1978@jiangnan.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

April 1, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)