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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patients will receive 177Lu-FAP-VG11 administration at an interval of 6 weeks between each dose.
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGDose-Limiting Toxicities (DLT)
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Time frame: Through study completion, assessed up to 2 years.
Maximum Tolerate dose (MTD)
Evaluating the safety and tolerability of the 177Lu-FAP-VG11 injection in patients.
Time frame: Through study completion, assessed up to 2 years.
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.
Time frame: Through study completion, assessed up to 2 years.
Biodistribution
Evaluation of drug biodistribution in major human organs.
Time frame: Through study completion, assessed up to 2 years.
Radiation dosimetry
Standard uptake value (SUV).
Time frame: Through study completion, assessed up to 2 years.
Radiation dosimetry
Organ accumulation (%ID).
Time frame: Through study completion, assessed up to 2 years.
Radiation dosimetry
Absorbed dose (AD).
Time frame: Through study completion, assessed up to 2 years.
Radiation dosimetry
Effective dose (ED) in tumors and target organs.
Time frame: Through study completion, assessed up to 2 years.
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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).
Time frame: Through study completion, assessed up to 2 years.
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.
Time frame: Through study completion, assessed up to 2 years.