Phase II Trial of Lu-177 FAP-2286 in Patients With Carcinoma of Unknown Primary

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

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

20 Participants
are divided into 1 treatment group

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