Phase I First-in-Human Study of 68GaGa DOTA-5G Imaging and 177LuLu DOTA-ABM-5G Therapy in Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating a new theranostic pair, 68GaGa DOTA-5G and 177LuLu DOTA-ABM-5G, in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma PDAC. This early phase I, first-in-human study aims to assess the safety and effectiveness of these agents and to determine the recommended dose for future studies. The study hypothesizes that 68GaGa DOTA-5G can detect cancer lesions and that the pair will be safe and tolerable for treatment. Participants first undergo PETCT scans using 68GaGa DOTA-5G to confirm eligibility based on lesion uptake. Those eligible receive escalating doses of 177LuLu DOTA-ABM-5G ranging from 25 to 200 mCi in a standard 33 dose escalation design to identify dose limiting toxicities and the recommended phase 2 dose RP2D. After dose escalation, an additional group of 10 patients receives the RP2D to gather further safety and response data. During the study, participants will be monitored with imaging and clinical assessments at specific time points, including PETCT scans two hours after injection and evaluation of dose escalation effects 30 days post-injection. Organ dosimetry will be assessed 7 to 14 days after treatment. The study involves no randomization or masking, focusing on safety and initial response in this patient population. The total involvement duration varies according to dose escalation and expansion phases.

First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer