At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at time of informed consent
- ✓Signed informed consent prior to study-specific evaluation
- ✓Consent to submission of fresh or archival tumor tissue if available
- ✓ECOG performance status 0 or 1
- ✕Active malignancy except the specific cancer under investigation
- ✕Symptomatic or untreated CNS metastases or leptomeningeal disease or primary CNS tumor
- ✕Anticancer treatment within ≤14 days prior (≤28 days for checkpoint/antibody inhibitors)
- ✕Prior radiopharmaceutical therapy or EBRT to >25% bone marrow or direct EBRT to kidney
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating 68Ga-FAP-2286 and 177Lu-FAP-2286 for Solid Tumor. Currently recruiting, targeting 222 participants across 40 sites in 6 countries.
Signals
Detailed Summary
Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves. Given the restricted expression profile, FAP is a promising target for peptide-targeted radionuclide imaging and therapeutic agents. Phase 1 of this study is designed to evaluate the safety and establish the recommended intravenous (IV) Phase 2 dose (RP2D) for \[177Lu\]Lu FAP 2286 monotherapy in participants with FAP expressing solid tumors. Phase 2 is designed to evaluate the safety and efficacy of \[177Lu\]Lu FAP 2286 as monotherapy in participants with pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and breast cancer (BC) and in combination with chemotherapy in participants with untreated PDAC or relapsed NSCLC. Participants in both Phase 1 and 2 will be selected for treatment with \[177Lu\]Lu FAP 2286 based on \[68Ga\]Ga FAP 2286 imaging for determining tumor FAP expression.
Study Details
Timeline
Interventions
68Ga-FAP-2286 IV administered as imaging agent for PET scan.
Phase 1: Patients with positive uptake of 68Ga-FAP- 2286 will receive a fixed dose of 177Lu-FAP-2286 IV administered every 6 weeks for a maximum of 6 doses. Doses range between 3.7 and 9.25 GBq (100-250 mCi). Phase 2: Monotherapy: Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D determined in Phase 1 dose escalation in every 4 weeks. Combination therapy: Patients with positive uptake of 68Ga FAP 2286 will receive 177Lu-FAP-2286 based on dose escalation (starting with dose level 1) followed by dose expansion at selected dose.