Status:
RECRUITING
A Trial of HRS-6768 in Patients With Advanced Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 patien...
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- 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.
- There must be at least one evaluable lesion .
- ECOG 0-1
- The functions of major organs are in good condition.
Exclusion
- The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
- 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.
- 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.
- 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).
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06925581
Start Date
April 24 2025
End Date
April 1 2027
Last Update
December 3 2025
Active Locations (2)
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1
Beijing Gaobo Hospital
Beijing, Beijing Municipality, China, 102206
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032