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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

Beijing Gaobo Hospital

Beijing, Beijing Municipality, China, 102206

2

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032