About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 177Lu-FAP-2286
Treatment groups
Sponsors and collaborators
Peter MacCallum Cancer Centre, Australia
Lead sponsor
National Health and Medical Research Council, Australia
Collaborator
Novartis
Collaborator
SOFIE
Collaborator
University of Melbourne
Collaborator