Solid TumorsEarly Phase 1NCT07505069
Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors
A Early Phase 1 study testing RT01-89Zr in people with Solid Tumors, run by Nanolattix Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RT01-89Zr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to 28 Feb 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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..
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122
Jingchun Yu, 0510-68089404, kjc68088861@163.com
About this study
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.
- Conditions
- Solid Tumors
- Being tested
- RT01-89Zr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT01-89ZrDrug
Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi
| Study group | Role | What they receive |
|---|---|---|
| RT01-89Zr | Experimental | Not described Receives: Drug: RT01-89Zr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
The number and percentage of patients with adverse events/serious adverse events
Measured: Within 21 days after administration
Secondary outcomes (8)
Biological distribution
Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images
Measured: 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
Measured: 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)
Measured: through study completion, an average of 3 months
Semi-quantitative analysis
Standard uptake values (SUVmax, SUVmean)
Measured: 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
Measured: through study completion, an average of 3 months
Biological distribution
Retention time of each organ of interest through RT01-89Zr PET/CT images
Measured: 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
Measured: through study completion, an average of 3 months
Semi-quantitative analysis
Target-to-background ratio (TBR) (background can include mediastinum, general background, liver, muscle);
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start29 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanolattix Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505069
- Sponsor's protocol ID
- QM-RT01-2551
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors
- ClinicalTrials.gov ID
- NCT07505069
- Acronym / sponsor ID
- QM-RT01-2551
- Conditions
- Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nanolattix Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT01-89Zr | Experimental | Drug: RT01-89Zr |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT01-89ZrIntravenous injection of RT01-89Zr with a dosage of 1-2 mCi | Drug | RT01-89Zr |
Primary outcome
Safety evaluation
Time frame: Within 21 days after administration
The number and percentage of patients with adverse events/serious adverse events
8 secondary outcomes
Biological distribution
Time frame: through study completion, an average of 3 months
Radiation Dosimetry
Time frame: through study completion, an average of 3 months
Visual Analysis
Time frame: through study completion, an average of 3 months
Semi-quantitative analysis
Time frame: through study completion, an average of 3 months
Probe Targeting Performance Analysis
Time frame: through study completion, an average of 3 months
Biological distribution
Time frame: through study completion, an average of 3 months
Biological distribution
Time frame: through study completion, an average of 3 months
Semi-quantitative analysis
Time frame: through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RT01-89Zr in people with Solid Tumors, run by Nanolattix Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingchun Yu (0510-68089404, ycjwxd1978@jiangnan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: Within 21 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.