A PHASE 1, FIRST IN HUMAN STUDY OF TORL-4-500 IN PATIENTS WITH ADVANCED CANCER
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Gyn/Onc (OB/GYNONC), Sarcoma (ONC), Thoracic (ONC)
Current Status: Not open
Phase: I (Cancer Control)
Principal Investigator: Klute, Kelsey
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06005740?term=NCT06005740&rank=1#participation-criteria
Summary
Primary Objective: To characterize the safety, tolerability, and DLT and to determine the MTD and the RP2D of TORL-4-500 administered as monotherapy in patients with advanced cancer
Secondary Objectives: -To characterize the PK of TORL-4-500 and its breakdown products (MMAE and TORL-4-500-MAB). -To assess the preliminary antitumor activity of TORL-4-500 in patients with advanced cancer. -To assess the immunogenicity of TORL-4-500
Exploratory Objectives: To assess for potential correlations of DLK1 protein expression level in archival samples with antitumor activity