Fibroblast Activation Protein (FAP)-Positive Advanced Solid Tumours
Conditions
Brief summary
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.
Detailed description
This is an exploratory, single-arm, dose-escalation, open-label early Phase I clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of 177Lu-FAP-VG11 injection in FAP-positive patients with advanced solid tumors.
Interventions
DRUG177Lu-FAP-VG11
Patients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicities (DLT) | Through study completion, assessed up to 2 years. | Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients. |
| Maximum Tolerate dose (MTD) | Through study completion, assessed up to 2 years. | Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients. |
| Adverse Events | Through study completion, assessed up to 2 years. | 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 | Through study completion, assessed up to 2 years. | Evaluation of drug biodistribution in major human organs. |
| Radiation dosimetry | Through study completion, assessed up to 2 years. | Standard uptake value (SUV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Through study completion, assessed up to 2 years. | 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) | Through study completion, assessed up to 2 years. | DOR is defined as the time from the earliest date of documented CR or PR until documented disease progression or death, whichever occurs first. |
Countries
China
Contacts
CONTACTXiaorong Sun
Outcome results
None listed