177Lu-FAP-VG11 Injection for FAP-Positive Advanced Solid Tumours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase, single-arm study to assess safety, tolerability, and how the treatment distributes in the body (dosimetry) after administration of 177Lu-FAP-VG11. The trial uses a dose-escalation design to identify a tolerable dose range while monitoring preliminary signs of activity in patients whose tumours express fibroblast activation protein (FAP). Eligible participants have advanced solid tumours, are FAP-positive by PET imaging, and have exhausted standard therapies. The study is open-label and conducted at a single center in Shandong, China, sponsored by Shandong Cancer Hospital and Institute. Results will inform future development of targeted radioligand therapy for FAP-expressing cancers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
* Patients whose tumors are assessed as FAP-positive (high FAP expression with SUVmax uptake above liver background) by FAP-targeted diagnostic PET/CT imaging.
* In the investigator's judgment, no other treatment option with curative or life-prolonging potential is available.
* Male or non-pregnant, non-lactating females, aged ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
* Life expectancy \>6 months.
* Female patients: Women of childbearing potential must agree to use highly effective contraceptive methods from screening until 6 months after the last dose of study drug.
* Male patients: Subjects must use a condom during sexual intercourse during the study and for 14 weeks after the last study treatment to prevent partner pregnancy and to avoid transmission of the study drug via semen; in addition, subjects should refrain from sperm donation during treatment and for 6 months after the last study drug administration.
* Subjects must provide written informed consent voluntarily before participation in the trial.
* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

* Clinically symptomatic central nervous system metastases or meningeal metastases, or other evidence that the patient's central nervous system or meningeal metastases are not controlled, and deemed unsuitable for enrollment by the investigator.
* Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of study drug, or need for elective surgery during the study period.
* History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or severe autoimmune disease history deemed unsuitable for enrollment by the investigator; or allogeneic organ transplantation requiring immunosuppressive therapy.
* Receipt of systemic or local radioisotope therapy within 3 months prior to the first dose.
* Receipt of other investigational drugs not yet marketed within 4 weeks prior to the first use of study drug, or within five half-lives of the other investigational drug.
* Definitive history of neurological or psychiatric disorders, including epilepsy or dementia.
* Pregnancy or lactation, or unwillingness to use adequate contraceptive methods.
* Any severe concomitant disease that, in the investigator's opinion, would make the patient's participation in the study inadvisable or could affect compliance with the protoco.

Where it's running

• Cancer Hospital of Shandong First Medical University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Xiaorong Sun
• Email: xrsun@sdfmu.edu.cn
• Phone: 0531-67626287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.