Actively Recruiting
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
Led by ITM Oncologics GmbH · Updated on 2025-10-20
270
Participants Needed
10
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide written informed consent before any study procedures.
- For Parts A, B, and C: Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors including clear cell renal cell cancer, pancreatic ductal adenocarcinoma, colorectal cancer, and urothelial carcinoma.
- Renal cell cancer participants must have received at least one tyrosine kinase inhibitor and one immune checkpoint inhibitor treatment in metastatic setting.
- Pancreatic cancer participants must have had at least one line of platinum- and/or gemcitabine-based treatment.
- Colorectal cancer participants must have received FOLFIRINOX or FOLFOX/FOLFIRI with anti-VEGF or anti-EGFR treatments.
- Availability of fresh or archival tumor biopsy for colorectal and pancreatic cancer participants.
- Urothelial cancer patients (Parts B and C) must have received all standard care including chemotherapy and immunotherapies.
- Presence of at least one non-irradiated measurable tumor lesion confirmed by CT or MRI within 4 weeks before [68Ga]Ga-DPI-4452 administration.
- For Part D: Imaging evidence of a single indeterminate renal mass ≤7 cm planned for nephrectomy or biopsy within 90 days of [68Ga]Ga-DPI-4452 administration.
- For Part E: Histologically or cytologically confirmed progressive unresectable locally advanced or metastatic tumors including urothelial carcinoma, muscle invasive bladder cancer, head and neck cancer, triple negative breast cancer, squamous non-small cell lung cancer, or other tumors with confirmed carbonic anhydrase IX expression (excluding ccRCC, PDAC, CRC).
- Presence of at least one non-irradiated tumor lesion confirmed by imaging within 4 weeks before [68Ga]Ga-DPI-4452 administration.
You will not qualify if you...
- Any major surgery within 12 weeks prior to enrollment.
- Unable to stay in the scanner bed with arms positioned outside thoracic and abdominal areas for the scan duration.
- Known hypersensitivity to the active substances, excipients of DPI-4452, or radiographic contrast agents.
- Bladder outflow obstruction or unmanageable urinary incontinence.
- Unresolved clinically significant toxic effects from prior cancer therapy, surgery, or radiotherapy except specified exceptions.
- Prior administration of radiopharmaceuticals within defined washout periods.
- Previous carbonic anhydrase IX-targeting treatment within specified timeframes.
- Prior external beam radiation therapy to more than 25% of bone marrow.
- Active clinically significant cardiac disease.
- Recent systemic antineoplastic therapy or investigational agents within specified timeframes.
- Inflammatory bowel diseases such as Crohn's or ulcerative colitis.
- Presence of malignant disease other than the one being treated in the study, except certain treated malignancies without recurrence within 2 years.
- Ongoing treatment with sulfonamides or coumarin derivatives within 2 weeks prior to [68Ga]Ga-DPI-4452 injection.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Peter MacCallum Cancer Centre
Melbourne, Australia, VIC 3000
Actively Recruiting
2
UNSW Sydney, St Vincent's Hospital Sydney
Sydney, Australia, NSW 2010
Actively Recruiting
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
4
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
5
CHU de Grenoble-Alpes, Boulevard de la Chantourne
Grenoble, France, 38043
Actively Recruiting
6
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
7
AP-HM - Hopital de la Timone
Marseille, France, 13005
Actively Recruiting
8
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
9
IUCT - Oncopole
Toulouse, France, 31100
Actively Recruiting
10
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
I
ITM Oncologics GmbH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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