Patients With Solid TumorsPhase 1/2NCT07070349
A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
A Phase 1/2 study testing HRS-6213 in people with Patients With Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Solid Tumors
- What is being tested?
- HRS-6213
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to Mar 2026
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form; willing and able to follow the study protocol.
- For healthy subjects：BMI 18~28kg/m2
- For patients：
- ECOG 0-1
- Patients with pathologically confirmed tumour
- proposed surgical resection/exploration (including primary or recurrent metastatic tumour
- sufficient organs function.
Who cannot join
- Known severe allergic reactions, hypersensitivity or contraindications to the test drug or any component of its preparation, such as alcohol allergy or other allergic history that the investigator deems may increase the risk of the trial.
- Received the following treatments before administration:
- Received radionuclide diagnostic or therapeutic drugs before administration, and less than 10 physical half-lives have elapsed since the last administration.
- Used any intravenous iodinated contrast agent within 24 hours before administration, or used any high-density oral contrast agent within 5 days before administration (oral water-based contrast agent is acceptable).
- Concurrent infectious diseases
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction.
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- Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration.
- Unexplained fever > 38.5℃ lasting for more than 1 hour during screening or before administration.
- Concurrent severe or poorly controlled cardiac diseases or symptoms, including but not limited to: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 6 months before administration, QTcF > 450 msec in males or QTcF > 470 msec in females.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
- Conditions
- Patients With Solid Tumors
- Being tested
- HRS-6213
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6213Drug
HRS-6213 IV administered as imaging agent for PET scan.
| Study group | Role | What they receive |
|---|---|---|
| HRS-6213 | Experimental | Not described Receives: Drug: HRS-6213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of adverse events (AEs) of HRS-6213
To evaluate the safety and tolerability of HRS-6213.
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Radiation dosimetry
To evaluate the distribution of radioactivity in tissues and organs, and obtain the accumulation in major organs, time-radioactivity curves, internal radiation absorbed doses of the whole body and major organs of HRS-6213
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 2: With reference to the Standard of Truth (SOT), evaluate the diagnostic efficacy indicators of HRS-6213 PET at the lesion level
evaluate the diagnostic efficacy indicators of HRS-6213.
Measured: rom first dose of study drug to end of treatment (up to approximately 60 days)
Secondary outcomes (9)
Phase 1: Cmax
To evaluate the PK of HRS-6213
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Biological half-life (t½)
To evaluate the PK of HRS-6213
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Tmax
To evaluate the PK of HRS-6213
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: urinary cumulative excretion rate
To evaluate the PK of HRS-6213
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Lesion uptake curve
Lesion uptake curve of lesions detected by PET scans at different time points HRS-6213.
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Image quality score
Imaging quality scores of HRS-6213 with Likert image quality rating scale and signal-to-noise ratio.
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 2: The proportion of subjects with changes in disease staging and treatment decisions before and after HRS-6213 PET imaging.
changes in disease staging and treatment decisions due to diagnostic test.
Measured: From first dose of study drug to end of treatment (up to approximately 60 days)
Phase 2: Intra-observer consistency of the diagnosticians' results
consistency of the diagnosticians' results by investigators.
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 2:Incidence of adverse events (AEs) of HRS-6213
To evaluate the safety and tolerability of HRS-6213.
Measured: From first dose of study drug to end of treatment (up to approximately 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start10 Jul 2025
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Solid TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070349
- Sponsor's protocol ID
- HRS-6213-101
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07070349
- Acronym / sponsor ID
- HRS-6213-101
- Conditions
- Patients With Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Jul 2025 (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.
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-6213 | Experimental | Drug: HRS-6213 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily sign the informed consent form; willing and able to follow the study protocol.
- For healthy subjects：BMI 18~28kg/m2
- For patients：
Key exclusion criteria (9 listed)
- Known severe allergic reactions, hypersensitivity or contraindications to the test drug or any component of its preparation, such as alcohol allergy or other allergic history that the investigator deems may increase the risk of the trial.
- Received the following treatments before administration:
- Concurrent infectious diseases
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction.
- Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration.
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 |
|---|---|---|
| HRS-6213HRS-6213 IV administered as imaging agent for PET scan. | Drug | HRS-6213 |
Primary outcome
Phase 1: Incidence of adverse events (AEs) of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the safety and tolerability of HRS-6213.
Phase 1: Radiation dosimetry
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the distribution of radioactivity in tissues and organs, and obtain the accumulation in major organs, time-radioactivity curves, internal radiation absorbed doses of the whole body and major organs of HRS-6213
Phase 2: With reference to the Standard of Truth (SOT), evaluate the diagnostic efficacy indicators of HRS-6213 PET at the lesion level
Time frame: rom first dose of study drug to end of treatment (up to approximately 60 days)
evaluate the diagnostic efficacy indicators of HRS-6213.
9 secondary outcomes
Phase 1: Cmax
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Biological half-life (t½)
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Tmax
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: urinary cumulative excretion rate
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Lesion uptake curve
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 1: Image quality score
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 2: The proportion of subjects with changes in disease staging and treatment decisions before and after HRS-6213 PET imaging.
Time frame: From first dose of study drug to end of treatment (up to approximately 60 days)
Phase 2: Intra-observer consistency of the diagnosticians' results
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Phase 2:Incidence of adverse events (AEs) of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
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 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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 Phase 1/2 study testing HRS-6213 in people with Patients With Solid Tumors, run by Jiangsu HengRui Medicine 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 9 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 12 Aug 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiao Chen (0518-82342973, xiao.chen.xc1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Incidence of adverse events (AEs) of HRS-6213 (time frame: From first dose of study drug to end of treatment (up to approximately 7 days)). The study lists 3 primary outcomes in all. 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 12 Aug 2025.