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A Trial of HRS-6768 in Patients With Advanced Solid Tumors

A Trial of HRS-6768 in Patients With Advanced Solid Tumors

Recruiting
18-80 years
All
Phase 1/2

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Overview

The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.

Eligibility

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods.
  3. There must be at least one measurable lesion as the target lesion (according to the RECIST V1.1 criteria).
  4. ECOG 0-1
  5. The functions of major organs are in good condition.

Exclusion Criteria:

  1. The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
  2. The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose.
  3. The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose.
  4. The patient has had a severe infection (CTCAE > Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).

Study details
    Advanced Solid Tumors

NCT06925581

Jiangsu HengRui Medicine Co., Ltd.

23 May 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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