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

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monoth

Trial Details

NCT ID
NCT05706129
Phase
PHASE1 / PHASE2
Sponsor
ITM Oncologics GmbH
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • [68Ga]Ga-DPI-4452
  • [177Lu]Lu-DPI-4452
Locations (sample)
  • Melbourne, Australia|-37.814,144.96332
  • Sydney, Australia|-33.86785,151.20732
  • Clermont-Ferrand, France|45.77969,3.08682
  • Dijon, France|47.31344,5.01391
  • Grenoble, France|45.17869,5.71479

Key Eligibility Criteria

  • Part A, B, and C:
  • Written informed consent, dated and signed by the patient prior to any study-specific procedure.
  • Part B and C are not conducted in the United States of America.
  • Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Adenocarcinoma Lung Cancer Trials on Trialify →