This is an exploratory clinical study evaluating the safety, tolerability and biodistribution characteristics of 177Lu-FAP-VG11 injection in patients with FAP-positive advanced solid tumours.
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.
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.
Single group
177Lu-FAP-VG11
DrugPatients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose.
Dose-Limiting Toxicities (DLT)
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Maximum Tolerate dose (MTD)
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Adverse Events
Patients adverse events Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v6.0.All Adverse Events (AEs) occurring during the clinical study period will be monitored.
Biodistribution
Evaluation of drug biodistribution in major human organs.
Objective Response Rate (ORR)
ORR is defined as the the proportion of subjects who achieve a best overall response of Complete Response (CR) or Partial Response (PR).
Duration of Response (DOR)
DOR is defined as the time from the earliest date of documented CR or PR until documented disease progression or death, whichever occurs first.
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