A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)

Open to people ages 18 years and up

• Be ≥ 18 years of age at the time the ICF is signed.
• Consent to submission of archival tumor tissue, if available.
• Adequate bone marrow, hepatic, and renal function.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 6 months.

• Measurable disease per RECIST v1.1.

  Phase 1 only: • Patients must have an advanced/metastatic solid tumor that is refractory to or has progressed following prior treatment and has no satisfactory alternative treatment options. Phase 2 only: • Patient enrolled in Phase 2 will have one of several specific FAP-expressing tumor types with advanced or recurrent or metastatic disease following prior therapy.

• Active second malignancy that may interfere with the safety or efficacy assessments of this study
• Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease or with primary tumor of CNS origin. Patients must be clinically stable for at least 4 weeks without steroid treatment
• Received anticancer treatment ≤ 14 days prior to receiving study treatment (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies)
• Received prior radiopharmaceutical therapy or radioembolization, 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 administration of study treatment
• Ongoing adverse effects from anticancer treatment > Grade 1, with the exception of alopecia
• Known incompatibility with contrast media for CT or PET scans. Infection requiring systemic antibiotics within 2 weeks prior to administration of study treatment
• Impaired cardiac function or clinically significant cardiac disease
• Severe urinary incontinence, voiding dysfunction, or urinary obstruction
• Minor surgery ≤ 5 days, or major surgery ≤ 21 days, prior to administration of study treatment.
• Any other condition that may increase the risk associated with study participation or interfere with its interpretation.
• Refusal to use highly effective method of contraception, as applicable
• Pregnant or breastfeeding
• Any other condition that may increase the risk associated with study participation or interfere with its interpretation.