NCT07070349 A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
| NCT ID | NCT07070349 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Patients With Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2025-07-10 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form; willing and able to follow the study protocol. 2. For healthy subjects：BMI 18\~28kg/m2 3. For patients： * ECOG 0-1 * Patients with pathologically confirmed tumour * proposed surgical resection/exploration (including primary or recurrent metastatic tumour * sufficient organs function. Exclusion Criteria: 1. 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. 2. Received the following treatments before administration: 1. Received radionuclide diagnostic or therapeutic drugs before administration, and less than 10 physical half-lives have elapsed since the last administration. 2. 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). 3. Concurrent infectious diseases 4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction. 5. Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration. 6. Unexplained fever \> 38.5℃ lasting for more than 1 hour during screening or before administration. 7. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07070349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Patients With Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07070349 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07070349 currently recruiting?
Yes, NCT07070349 is actively recruiting participants. Contact the research team at xiao.chen.xc1@hengrui.com for enrollment information.
Where is the NCT07070349 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07070349 clinical trial?
NCT07070349 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 48 participants.