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

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 of this study will evaluate the safety and tolerability of 177Lu-FAP-2286 and determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Phase 2 of this study is designed to evaluate objective response rate (ORR) in patients with specific solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.

Criteria

Inclusion Criteria:

• 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.

Patient enrolled in Phase 2 will have one of several specific tumor types with advanced or recurrent or metastatic disease following prior therapy.

Exclusion Criteria:

• 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 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.