Clinical trial · Interventional
A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
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
NCT07070349CI-TRIAL-00093528recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-6213 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-6213
- interventionNames
- Drug: HRS-6213
Primary outcomes (3)
- measure
- Phase 1: Incidence of adverse events (AEs) of HRS-6213
- timeFrame
- From first dose of study drug to end of treatment (up to approximately 7 days)
- description
- To evaluate the safety and tolerability of HRS-6213.
- measure
- Phase 1: Radiation dosimetry
- timeFrame
- From first dose of study drug to end of treatment (up to approximately 7 days)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.