Evaluating HRS-6768 for 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

This study is testing a new drug called HRS-6768 to see if it can help people with advanced solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06925581 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the pharmacokinetics, safety, and preliminary efficacy of HRS-6768 in patients with advanced solid tumors. It focuses on determining the appropriate dosage for patients who have not responded to standard treatments or lack effective options. Participants will be monitored for measurable lesions and overall health to evaluate the drug's impact on their condition.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced-stage solid tumors that are unresectable or metastatic and have failed standard treatment.

Not a fit: Patients who have experienced significant weight loss recently or have received prior radiopharmaceutical therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in evaluating new treatments for advanced solid tumors.

Eligibility criteria

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 evaluable lesion .
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).

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Gaobo Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zengquan Gu

Conditions Advanced Solid Tumors