The aim of the study is to test if a new radionuclide therapy, called 177-Lu-FAP-2286, works to treat cancer in patients with Cancer of Unknown Primary (CUP).
Patient has provided written informed consent
Patients aged 18 years or over at Screening
Diagnosed with CUP based on a diagnostic work-up, including, but not limited to; a detailed clinical assessment; a CT CAP; pathological review of tumour tissue; and other appropriate tests as per the Cancer Council Optimal Care Pathway guidelines.
Progressed on 1st line platinum doublet chemotherapy +/- immunotherapy +/- antibody therapy
Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment
Symptomatic and/or untreated central nervous system metastases or leptomeningeal disease. Patients must be clinically stable for at least 4 weeks without steroid treatment
Surgical procedure (minor surgery ≤ 5 days, or major surgery ≤ 21 days) prior to registration or active infection requiring systemic treatment Note: Placement of vascular access devices, laparoscopy and prophylactic procedures to stabilise bone lesions are not considered major surgical procedures
Received anticancer treatment ≤ 14 days prior to registration (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies)
Single group
177Lu-FAP-2286
Drug177Lu-FAP-2286 is a novel radioligand therapy. FAP-2286 is a small molecular ligand that binds to the fibroblast activated protein on cancer associated fibroblasts. Lutetium-177 (177Lu) is a nuclear reactor-produced radiometal with a half-life of 6.7 days. 250 mCi of 177Lu-FAP-2286 will be given once every 28 days for a maximum duration of 6 cycles of treatment.
Overall Response Rate (ORR)
ORR is defined as complete response (CR) or partial response (PR) as per RECIST1.1 at any time after commencement of treatment.
Progression Free Survival (PFS)
PFS will be measured from the date of treatment commencement to the first evidence of disease progression per RECIST1.1 oir death due to any cause
Evaluation of Safety
Safety will be evaluated by determining the type, grade and relationship to treatment of Adverse Events (AE's), assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
PERCIST response
18F-FDG-PET/CT response 12 weeks after commencement of FAP-directed radioligand therapy as per PERCIST
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Peter MacCallum Cancer Centre, Australia
Lead sponsor
National Health and Medical Research Council, Australia
Collaborator
Novartis
Collaborator
SOFIE
Collaborator
University of Melbourne
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
