RecruitingPhase 1Phase 2NCT06925581

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

A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

84 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

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 patients with advanced solid tumors.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria4

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).

Interested in this trial?

Get notified about updates and connect with the research team.