Study of Safety, Tolerability, and Effectiveness of 68GaGa-DPI-4452 and 177LuLu-DPI-4452 in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and imaging characteristics of 68GaGa-DPI-4452, as well as the safety, tolerability, and efficacy of 177LuLu-DPI-4452 in participants with unresectable locally advanced or metastatic solid tumors. This phase 12, open-label, non-randomized study involves multiple tumor types including clear cell renal cell cancer, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma, and others with confirmed carbonic anhydrase IX expression. The study aims to identify appropriate dosing and assess preliminary antitumor activity and diagnostic concordance with histopathology results. Participants receive a single intravenous dose of 68GaGa-DPI-4452 for imaging purposes during screening. The study includes parts where escalating doses of 177LuLu-DPI-4452 are administered intravenously every 4 or 6 weeks to determine the recommended phase 2 dose. Subsequently, participants receive the recommended dose on Day 1 of each treatment cycle. Separate parts of the study focus on evaluating uptake in various tumors and assessing diagnostic accuracy. Treatment schedules and dosing vary by study part and tumor type. Throughout the study, participants undergo PET imaging, blood and urine sampling, and assessments for adverse events and tumor responses. Researchers monitor for treatment-emergent and serious adverse events, dose-limiting toxicities, objective response rates, progression-free and overall survival, and disease control rates over periods up to 81 months. Imaging and biopsy samples are used to evaluate tumor lesions and diagnostic concordance. Safety and efficacy outcomes are carefully tracked during and after treatment cycles.

A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors