OncoMatch/Clinical Trials/NCT05706129
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
Is NCT05706129 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 for clear cell renal cell cancer (ccrcc).
Treatment: [68Ga]Ga-DPI-4452 · [177Lu]Lu-DPI-4452 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Pancreatic Cancer
Colorectal Cancer
Urothelial Carcinoma
Head and Neck Squamous Cell Carcinoma
Triple-Negative Breast Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: CA9 expression
Disease stage
Required: Stage III, IV, CT1 (IDRM ≤ 7 CM)
unresectable locally advanced or metastatic solid tumors; IDRM of ≤ 7 cm in largest diameter (tumor stage cT1)
Prior therapy
Must have received: tyrosine kinase inhibitor — metastatic
ccRCC - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment
Must have received: immune checkpoint inhibitor — metastatic
ccRCC - participants must have received at least one line containing immune checkpoint inhibitor treatment
Must have received: platinum-based chemotherapy
PDAC - participants must have received at least one line of platinum- and/or gemcitabine-based regimen
Must have received: gemcitabine (gemcitabine)
PDAC - participants must have received at least one line of platinum- and/or gemcitabine-based regimen
Must have received: FOLFIRINOX (FOLFIRINOX)
CRC - participants must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR)
Must have received: FOLFOX (FOLFOX)
CRC - participants must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR)
Must have received: FOLFIRI (FOLFIRI)
CRC - participants must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR)
Must have received: anti-VEGF therapy
CRC - ...in combination with anti-Vascular Endothelial Growth Factor (VEGF)
Must have received: anti-EGFR therapy
CRC - ...in combination with anti-Epidermal Growth Factor Receptor (EGFR)
Must have received: platinum-based chemotherapy
UC patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab
Must have received: antibody-drug conjugate (enfortumab vedotin)
UC patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab
Must have received: anti-PD-1 therapy (pembrolizumab)
UC patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab
Cannot have received: CA9-targeting treatment
Previous Carbonic anhydrase (CA) IX-targeting treatment
Cannot have received: radiopharmaceutical
Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-DPI-4452
Cannot have received: radiopharmaceutical with therapeutic intent
Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of [68Ga]Ga-DPI-4452
Cannot have received: external beam radiation therapy
Exception: to more than 25% of the bone marrow
Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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