Treatment of advanced metastatic tumors using 177Lu-JH04
Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
This study is testing a new treatment called 177Lu-JH04 for people with advanced metastatic tumors to see if it can help them when other treatments have failed.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06636617 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety, dosimetry, and response of a new radiopharmaceutical, 177Lu-JH04, targeting fibroblast activation protein (FAP) in patients with advanced metastatic tumors. Patients are selected based on high FAP expression confirmed through 68Ga-FAPI PET/CT imaging and are divided into three groups to receive varying doses of the treatment over up to four cycles. The study aims to assess the efficacy and toxicity of this targeted therapy in individuals who have exhausted other treatment options.
Who should consider this trial
Good fit: Ideal candidates include patients with progressive advanced metastatic tumors that have high FAP expression.
Not a fit: Patients who are pregnant, lactating, or have received recent anti-tumor therapies 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 metastatic tumors that express FAP.
How similar studies have performed: Other studies targeting FAP with radiopharmaceuticals have shown promising efficacy and safety profiles, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * progressive advanced metastatic tumors * tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT * adequate renal, haematological, and liver function * an Eastern Cooperative Oncology Group performance status of 0-2 Exclusion Criteria: * pregnant or lactating women * received other radionuclide therapy in the past 6 months * received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days
Where this trial is running
Fuzhou, Fujian
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Weibing Miao, MD — The First Affiliated Hospital, Fujian Medical University
- Study coordinator: Weibing Miao, MD
- Email: miaoweibing@126.com
- Phone: +86-0591-87981618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.