A Trial of HRS-6213 in Healthy Subjects and Patients With Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Patients With Solid Tumors

Treatments: Drug: HRS-6213

Study type: Interventional

Funder types: Industry

Identifiers

NCT07070349

HRS-6213-101

Details and patient eligibility

About

The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

HRS-6213

Experimental group

Treatment:

Drug: HRS-6213