Phase II Trial of Lu-177 FAP-2286 in Patients With Carcinoma of Unknown Primary (NCT07434180) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Trial of Lu-177 FAP-2286 in Patients With Carcinoma of Unknown Primary
Australia20 participantsStarted 2026-06
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 68Ga-FAPI-46 positive disease on 68Ga-FAPI-46-PET/CT defined as 68Ga-FAPI-46 uptake at PET/CT with SUVmax of ≥ 8 in at least 50% of target lesions and above surrounding background in the remaining target lesions
. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 1).
. Life expectancy greater than 3 months
. Adequate bone marrow, hepatic and renal function defined by the following laboratory results:
Exclusion criteria
. Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: From start of treatment until end of follow-up (study completion- 2 years after the last patient has commenced 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)
. Severe impaired cardiac function (left ventricular ejection fraction \< 35%) or clinically significant uncontrolled cardiac disease
. Severe urinary incontinence, voiding dysfunction, or unrelieved urinary obstruction
. Ongoing AEs from anticancer treatment \> Grade 1 as per CTCAE v5.0, with the exception of alopecia
. Received prior radiopharmaceutical therapy or radioembolisation, or prior extensive external beam radiation therapy (EBRT) to bone marrow or any prior EBRT directly to kidney or received any EBRT within 2 weeks prior to registration