for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



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 tumor-specific cohorts of patients with a FAP-expressing solid tumor.

Official Title

LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor


Solid Tumor, 177Lu-FAP-2286, 68Ga-FAP-2286, theranostic, FAP-2286, FAP, fibroblast activation protein, dosimetry, CAF, cancer-associated fibroblasts, Peptide-Targeted Radioligand Therapy, PTRT, Peptide Receptor RadionuclideTherapy, PRRT, TRT, Targeted radioligand therapy, Target radionuclide therapy, Lutetium-177, Gallium-68, Neoplasms, Specific Solid Tumors


You can join if…

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.

You CAN'T join if...

  • 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.


  • UCSF Medical Center accepting new patients
    San Francisco California 94158 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States


accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 1/2 research study
Study Type
Expecting 300 study participants
Last Updated