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

Exclusion Criteria

• •Patients who meet any of the following criteria will be excluded from trial entry:
• •1. Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment
• •2. Symptomatic and/or untreated central nervous system metastases or leptomeningeal disease. Patients must be clinically stable for at least 4 weeks without steroid treatment
• •3. 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
• •4. Received anticancer treatment ≤ 14 days prior to registration (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies)
• •5. Severe impaired cardiac function (left ventricular ejection fraction \< 35%) or clinically significant uncontrolled cardiac disease
• •6. Severe urinary incontinence, voiding dysfunction, or unrelieved urinary obstruction
• •7. Ongoing AEs from anticancer treatment \> Grade 1 as per CTCAE v5.0, with the exception of alopecia
• •8. 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
• •9. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo procedures outlined in this protocol with reasonable safety
• •10. Prior cancer diagnosis with the exception of:
• •* Malignancy treated with curative intent and with no known active disease ≥ 3 years and of low potential risk of recurrence
• •* Adequately treated basal cell or squamous cell skin carcinoma or non-invasive melanoma
• •* Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)
• •* Adequately treated carcinoma in situ without evidence of disease
• •11. Cancer patients with incidental histologic findings of prostate cancer that, in the opinion of the Investigator, is not deemed to require active therapy (e.g., incidental prostate cancer identified following cystoprostatectomy that is tumour/node/metastasis stage ≤ pT2N0)
• •12. Greater than one prior line of systemic treatment
• •13. Known allergy or reaction to 18F, 68Ga or 177Lu radiopharmaceuticals
• •14. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in the protocol with reasonable safety