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 range18 Years

SexALL

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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
✕. 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

What they're measuring

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)

Trial details

NCT IDNCT07434180

SponsorPeter MacCallum Cancer Centre, Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06

Contact for this trial

Linda Mileshkin

+61 3 8559 5000 Contact.Bact@petermac.org

View on ClinicalTrials.gov More Cancer of Unknown Primary trials