Huntsman Cancer Institute listed a clinical trial to investigate the safety, tolerability, pharmacokinetics, dosimetry, and preliminary activity of 177
Lu Lu-FAP-2286 in participants with advanced solid tumors.
The multicenter, open-label, non-randomized study was designed as a Phase 1/2 trial.
The primary objectives of the Phase 1 portion of the study included evaluating the safety and tolerability of 177
Lu Lu-FAP-2286 and determining the recommended phase 2 dose (RP2D).
Secondary objectives for the Phase 1 stage involved measuring radiation dosimetry of 177
Lu Lu-FAP-2286, determining tumor uptake using 68
Ga Ga-FAP-2286, and evaluating the pharmacokinetics of 177
Lu Lu-FAP-2286. The study also aimed to evaluate preliminary efficacy in advanced solid tumors.
Phase 2 objectives included evaluating the objective response rate and the safety of 177
Lu Lu-FAP-2286 in combination with mFOLFIRNOX in pancreatic ductal adenocarcinoma (PDAC) and in combination with nab-paclitaxel in non-small cell lung cancer (NSCLC).
The study involved various disease sites including the biliary tract, bladder, brain, breast, cervix, colon, esophagus, gastrointestinal, genitourinary, head and neck, kidney, liver, lung, melanoma, neuroendocrine, ovary, pancreas, prostate, and sarcoma.
Participating institutions included the Huntsman Cancer Institute. Taryn Schnell-Patino served as Assistant Professor and Vaia Florou was identified as the Principal Investigator.