Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05706129 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT05706129 · ClinicalTrials.gov record · last posted 2026-08-11

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

StatusRecruiting
PhasePhase 1/2
Started2023-03-14
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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 monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \[68Ga\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \[68Ga\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.

Protocol amendment history 1 change detected by DataLookout

2026-08-09
notable
Sponsor changed: ITM Oncologics GmbH → Lumara Bio Oncologics GmbH
WasITM Oncologics GmbH
NowLumara Bio Oncologics GmbH
Trial Details
NCT Number NCT05706129
Lead Sponsor Lumara Bio Oncologics GmbH
Conditions Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Urothelial Carcinoma (UC), Indeterminate Renal Mass (IDRM), Muscle Invasive Bladder Cancer (MIBC), Head and Neck Cancer (H&N), Triple Negative Breast Cancer (TNBC) +1 more
Enrollment 270 participants
Start Date 2023-03-14
Primary Completion 2027-06 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-11