Evaluating HRS-6768 for advanced solid tumors
Official title: 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
Run by Jiangsu HengRui Medicine Co., Ltd. · NCT06925581 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | April 24, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2027 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT06925581 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with advanced-stage solid tumors that are unresectable or metastatic and have failed standard treatment.
✕Probably not a fit
Patients who have experienced significant weight loss recently or have received prior radiopharmaceutical therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is being explored in this trial, similar studies have shown promise in evaluating new treatments for advanced solid tumors.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Beijing Gaobo Hospital
Beijing, Beijing Municipality, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Zengquan Gu
- Email: zengquan.gu@hengrui.com
- Phone: 0518-82342973
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.