A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)
a study on Solid Tumor Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startestimated completion
Description
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 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
Keywords
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
Eligibility
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.
Locations
- 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
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Novartis Pharmaceuticals
- ID
- NCT04939610
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 300 study participants
- Last Updated